PAD: Chest Drainage Kit
FDA product code PAD. Class II, classified under 21 CFR 880.6740. What the classification flags say about Part 820 under the QMSR.
As of Nov 2, 2026, FDA product code PAD (Chest Drainage Kit) is Class II under 21 CFR 880.6740, reviewed through Enforcement discretion, with 0 linked 510(k), De Novo or BK numbers, 0 PMAs and 20 recall product records.
Classification
- Product code
- PAD
- Device name
- Chest Drainage Kit
- Device class
- Class II
- Regulation
- 21 CFR 880.6740
- Review panel
- General Hospital
- Premarket route
- Enforcement discretion
- CGMP-exempt flag
- Yes
- Life-sustaining flag
- No
- Implant flag
- No
- Third-party review
- Not a candidate
- Summary malfunction reporting
- Eligible
FDA definition. This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Data from openFDA as of 2 November 2026. Read the record on openFDA · FDA product code classification database
Part 820 requirements the flags point to
Part 820 rules for PAD
- CGMP exemptionClassification regulation, 21 CFR parts 862 to 892
- Database cannot sayFDA flags this code as exempt, but the regulation text has no exemption sentence.The flag says exempt. We read 21 CFR 880.6740 as of 2026-11-10 and found no sentence exempting the device from part 820. The regulation is the legal text. Check it, and ask FDA, before relying on the flag.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
- Design and development, ISO 13485 clause 7.321 CFR 820.10(c)
- Rule names this classRule names Class II.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses. This code is also flagged CGMP-exempt, so read the exemption above before assuming clause 7.3 applies.21 CFR 820.10
- Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d)
- Not flaggedFDA does not flag this code as life-supporting or life-sustaining.820.10(d) is not indicated by this flag.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
- Complaint and record content21 CFR 820.35
- Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions
These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.
Clearances and recalls on record
- 510(k), De Novo and BK numbers linked
- 0
- PMA numbers linked
- 0
- Recall product records
- 20
- Adverse event reports
- Search MAUDE for PAD
Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.
Search all 7,098 product codes, or read the guide to the Part 820 rules behind these flags.
Check your quality documents against Part 820
Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.