FDA Product Code Lookup

Data through 26 October 2026. Regulation text read as of 5 November 2026.

Product codes

7,097

Flagged CGMP-exempt

761

Flagged life-sustaining

226

Flagged implant

701

Codes and flags by device class

Class I

2,403 codes · 532 exempt · 0 life-sustaining · 3 implant

Class II

3,646 codes · 6 exempt · 150 life-sustaining · 406 implant

Class III

528 codes · 0 exempt · 62 life-sustaining · 236 implant

HDE

51 codes · 0 exempt · 10 life-sustaining · 32 implant

Unclassified

86 codes · 0 exempt · 0 life-sustaining · 10 implant

Not classified

383 codes · 223 exempt · 4 life-sustaining · 14 implant

Codes with the most linked 510(k) numbers

GEX: Powered Laser Surgical Instrument Class II

2,892 510(k) numbers

GEI: Electrosurgical, Cutting & Coagulation & Accessories Class II

2,320 510(k) numbers

LLZ: System, Image Processing, Radiological Class II

2,295 510(k) numbers

LYY: Latex Patient Examination Glove Class I

1,954 510(k) numbers

DZE: Implant, Endosseous, Root-Form Class II

1,550 510(k) numbers

GCJ: Laparoscope, General & Plastic Surgery Class II

1,431 510(k) numbers

ESD: Hearing Aid, Air-Conduction, Prescription Class I

1,367 510(k) numbers

HRS: Plate, Fixation, Bone Class II

1,332 510(k) numbers

DXN: System, Measurement, Blood-Pressure, Non-Invasive Class II

1,226 510(k) numbers

IYN: System, Imaging, Pulsed Doppler, Ultrasonic Class II

1,189 510(k) numbers

Codes with the most recall records

FPA: Set, Administration, Intravascular Class II

1,090 recall records

LRO: General Surgery Tray Class II

1,084 recall records

JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented… Class II

984 recall records

JAK: System, X-Ray, Tomography, Computed Class II

873 recall records

FRN: Pump, Infusion Class II

723 recall records

LNH: System, Nuclear Magnetic Resonance Imaging Class II

723 recall records

HSB: Rod, Fixation, Intramedullary And Accessories Class II

690 recall records

GEI: Electrosurgical, Cutting & Coagulation & Accessories Class II

644 recall records

OWB: Interventional Fluoroscopic X-Ray System Class II

638 recall records

DQY: Catheter, Percutaneous Class II

620 recall records

Product codes by review panel

Gastroenterology, Urology

614 codes

General, Plastic Surgery

562 codes

Microbiology

554 codes

Clinical Chemistry

527 codes

Cardiovascular

440 codes

General Hospital

394 codes

Dental

352 codes

Orthopedic

349 codes

Ophthalmic

345 codes

Clinical Toxicology

338 codes

Pathology

325 codes

Neurology

291 codes

Hematology

281 codes

Immunology

278 codes

Ear, Nose, Throat

269 codes

Obstetrics/Gynecology

269 codes

Anesthesiology

262 codes

Radiology

216 codes

Physical Medicine

210 codes

Medical Genetics

7 codes

Source: openFDA device classification endpoint, joined to openFDA 510(k), PMA and device recall data, and to the exemption sentences in 21 CFR parts 862 to 892 on eCFR. Counts are of records, not events. The snapshot is public.

A product code is a three-character identifier that FDA assigns to a category of device. FDA bases it on the classification in 21 CFR parts 862 to 892 and on the technology and intended use of the device. FDA occasionally changes codes over time.

Each code sits under a generic type of device. 21 CFR 860.3 defines a generic type as a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function or any other feature related to safety and effectiveness. The generic type has a classification regulation, and the regulation sets the class. A lookup runs from code to regulation to class.

A code names a category. It says nothing about one firm's product, and many firms share a code. The most common code in the snapshot, GEX (Powered Laser Surgical Instrument), has 2,892 linked 510(k) numbers.

Device class

Class I, II or III. FDA also lists unclassified, not classified and HDE. 2,403 codes are class I, 3,646 class II and 528 class III.

Regulation number

The classification regulation in 21 CFR 862 to 892. 899 codes have none, which is the case for most unclassified and not classified codes. Each number links to the text on eCFR.

Review panel

The CDRH specialty panel that reviews the category, such as Cardiovascular or Orthopedic.

CGMP-exempt flag

FDA's flag that the device is exempt from the good manufacturing practice requirements in part 820. 761 codes carry it. The text that governs is in the classification regulation, and each code page quotes it.

Life-sustaining flag

The device is essential to, or yields information essential to, the restoration or continuation of a bodily function important to the continuation of human life. That is the wording of 21 CFR 860.3. 226 codes carry it.

Implant flag

The device is placed into a surgically or naturally formed cavity and intended to remain for 30 days or more, unless the Commissioner determines otherwise (21 CFR 860.3). 701 codes carry it.

Premarket route

The submission type openFDA limits the code to: 510(k), PMA, 510(k) exempt, Contact ODE, HDE, enforcement discretion or EUA. FDA lists the values on its product code file page.

Linked 510(k) numbers, PMAs and recall records

Counts joined from openFDA. The section on counts below says how they are built and what they leave out.

Each code page also shows third-party review eligibility and eligibility for summary malfunction reporting. Those concern premarket review and adverse event reporting, not part 820.

The quality management system regulation (QMSR) took effect on 2 February 2026. It incorporates ISO 13485 by reference, and 21 CFR 820.10 says which parts of it apply to which device. The table lists the rules that classification fields can point to.

Every flag on this page describes the classification of a product code. It is not a determination for a specific device or manufacturer. How a manufacturer meets 820.10 depends on its own device and intended use. The tool shows the rule, the source and what the flag cannot tell you.

820.10(c) names class II and class III devices. It adds class I devices automated with computer software and five class I devices in a table: tracheobronchial suction catheters (868.6810), non-powdered surgeon's gloves (878.4460), protective restraints (880.6760), manual radionuclide applicator systems (892.5650) and radionuclide teletherapy sources (892.5740). In the snapshot, 11 product codes sit under those five regulations.

Class I covers 2,403 codes, and 532 of them carry the CGMP-exempt flag. The other 1,871 are not flagged. Of those, 11 are on the table. For the rest, the question is whether the device is automated with computer software, and the database does not record that. The page says so on each class I code and does not guess.

Unclassified, not classified and HDE codes fall outside the classes 820.10(c) names. FDA's QMSR page adds that devices made under an investigational device exemption are not exempt from 820.10(c).

820.10(d) requires manufacturers of devices that support or sustain life to comply with ISO 13485 clause 7.5.9.2. The rule limits this to devices whose failure to perform, when properly used in accordance with the labeling, can reasonably be expected to result in a significant injury. The CFR names the clause "Traceability for Implantable Devices".

The rule does not define "support or sustain life". In the 2024 final rule, FDA said the phrase is explained in 21 CFR part 860 and quoted the 860.3 definition of a life-supporting or life-sustaining device. The life-sustaining flag in the classification database uses the same words. 226 codes carry it: 150 in class II and 62 in class III, with the rest HDE or not classified.

FDA also said the scope of 820.10(d) is substantially similar to the old rule. Section 820.65 covered devices intended for surgical implant as well as life-sustaining devices. The QMSR text names only devices that support or sustain life. 820.3(b)says the ISO term "implantable medical device" means "implant" as 21 CFR 860.3 defines it, and the implant flag, set on 701 codes, follows that definition. Whether an implant that is not life-sustaining falls under clause 7.5.9.2 is a reading of the clause and the rule that this tool leaves to you. ISO 13485 is a paid standard, and this page quotes only what the CFR and FDA print.

The exemption lives in the classification regulation for the generic device. The class I general purpose reagent in 21 CFR 864.4010(b) reads:

If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Before the QMSR, the same sentence exempted the device from the quality system regulation "with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files." FDA's technical amendments of 4 December 2025(90 FR 55978) moved the references to 820.35 across the classification regulations. FDA described that rule as editorial in nature, with no new requirements. FDA's QMSR page states the effect: exemption from CGMP does not exempt manufacturers of finished devices from keeping complaint files or from the records 820.35 requires.

The flag leaves out some of what the text says. 17 of the 45 distinct exemption sentences in the snapshot make the exemption depend on the device not being labeled or represented as sterile. They cover 167 codes, and the flag does not record how a product is labeled.

Some regulations exempt one part of a generic device. 21 CFR 876.5250 exempts class I urine collectors not connected to an indwelling catheter and has no CGMP exemption sentence for the class II collectors that are. In 6 cases the flag is set although the regulation we read has no exemption sentence. The tool marks those codes unresolved and points to the regulation.

Exemption from 510(k) is a separate matter. 2,639 codes have the submission type 510(k) exempt, against 761 flagged CGMP-exempt. The 510(k) exemption has its own limits, set out in the section 9 of each part. 21 CFR 864.9, for one, removes the exemption when a device has a different intended use or a different fundamental scientific technology.

CBK is ventilator, continuous, facility use, class II under 21 CFR 868.5895. Class II puts it under 820.10(c). It carries the life-sustaining flag, so the tool points to 820.10(d) and leaves the significant-injury condition to the manufacturer. It is not flagged CGMP-exempt.

DXY is an implantable pacemaker pulse-generator, class III under 21 CFR 870.3610. It carries the implant flag and not the life-sustaining flag. The code shows why the two flags are separate: the data marks the device as an implant, and 820.10(d) names devices that support or sustain life.

KGO is surgeon's gloves, class I under 21 CFR 878.4460. That section is on the 820.10(c)(2) table, so clause 7.3 applies although the device is class I.

LEC is grinder, tissue, class I under 21 CFR 864.3010. It carries the CGMP-exempt flag, and the regulation text confirms it with the 820.35 exception. Complaint files and 820.35 records still apply.

Each code shows how many 510(k), De Novo and BK numbers openFDA links to it, how many PMA numbers, and how many recall product records. The clearance count is the length of the number list in the classification record. The build script checks the largest codes against the 510(k) endpoint, and the totals match. The PMA count is distinct PMA numbers, not supplements.

A recall record is one product in FDA's device recall database, so one recall event can add many records. Records without an initiation date are left out. The counts show how much activity a category has. They say nothing about how safe a category is. 174,881 clearance numbers are linked across 4,773 codes.

The classification data comes from openFDA, which republishes FDA's product classification database and lists its update frequency as monthly. FDA replaces its own product code download fileevery Sunday. This snapshot holds openFDA's copy as of 2026-10-26. The exemption sentences were read from eCFR as of 2026-11-05. A script rebuilds the snapshot, and the pages read the committed file.

openFDA marks its data as unvalidated. A code FDA changed after the snapshot date can differ here, so check FDA's product code classification database before relying on a class or a flag in a submission or a quality procedure.

What is an FDA product code?

A product code is a three-character identifier FDA assigns to a category of device. FDA bases it on the classification in 21 CFR parts 862 to 892 and on the technology and intended use of the device. It identifies a category, not one firm's product.

How do I find the product code for a device?

Search by device name or by the regulation number here. The 510(k) record of a similar cleared device also lists its product code, and the 510(k) search on this site can filter clearances by code.

Does a CGMP-exempt flag mean part 820 does not apply?

No. FDA says exemption from CGMP does not exempt a finished-device manufacturer from keeping complaint files or from the records 21 CFR 820.35 requires. The exemption sentence in the classification regulation can also carry conditions, such as the device not being labeled or represented as sterile, that the flag does not record.

Which class I devices have to follow design and development requirements?

21 CFR 820.10(c) names class I devices automated with computer software and five class I devices listed in a table (sections 868.6810, 878.4460, 880.6760, 892.5650 and 892.5740). The classification database has no software field, so it cannot tell you whether a class I device is automated with computer software.

Which devices support or sustain life under 820.10(d)?

The rule does not define the phrase. FDA said in the 2024 final rule that 21 CFR 860.3 explains it, and the database's life-sustaining flag uses the same wording. 820.10(d) also requires that failure to perform could reasonably be expected to result in a significant injury, which the flag cannot show.

How often is the product code data updated?

FDA replaces its product code download file every Sunday. openFDA lists its update frequency as monthly. The snapshot on this page is dated, and the dates are shown in the data block above the guide.

Is there an API or bulk download for product codes?

Yes. openFDA serves the data at api.fda.gov/device/classification.json, and FDA publishes a pipe-delimited file called foiclass.zip. This tool also offers the snapshot it reads as a JSON file.

• FDA 510(k) search: the clearances behind a product code and the predicates under it
• FDA recall search: what FDA has recalled for a given failure mode
• MAUDE database search: adverse event reports, searchable by product code
• FDA inspection search: what FDA cited at device manufacturers since the QMSR took effect
• QMSR and 21 CFR 820: the rule these flags point into