Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list DeVilbiss Healthcare with 36 510(k) clearances and 6 device recalls. The most recent is a 510(k) clearance dated Mar 26, 2026: DeVilbiss 5 Liter Oxygen Concentrator (555).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 26, 2026 | DeVilbiss 5 Liter Oxygen Concentrator (555)K253549 · CAW | 510(k) clearances |
| Dec 9, 2025 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)K250805 · CAW | 510(k) clearances |
| Mar 9, 2023 | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-ARClass II · The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specifi | Device recalls |
| Nov 18, 2022 | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-QClass II · The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings th | Device recalls |
| Sep 19, 2022 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XBClass II · An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) | Device recalls |
| Mar 23, 2018 | Drive DeVilbiss iGo 2 Portable Oxygen ConcentratorK172648 · CAW | 510(k) clearances |
| May 23, 2016 | DeVilbiss Model 7305P-D Powered Suction UnitClass II · A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. | Device recalls |
| Jan 21, 2016 | DeVilbiss DV6WM Wireless ModemK152810 · BZD | 510(k) clearances |
| Sep 18, 2015 | DeVilbiss Intellipap2/DeVilbiss BLUEK143677 · BZD | 510(k) clearances |
| Aug 4, 2014 | DEVILBISS SMARTLINK II SYSTEMK140880 · BZD | 510(k) clearances |
| May 13, 2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Class III · A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the u | Device recalls |
| Mar 7, 2013 | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' pClass II · End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, ther | Device recalls |
| Nov 22, 2011 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVELK112220 · BZD | 510(k) clearances |
| Jun 13, 1997 | DEVILBISS 8650DK963349 · BTI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
