Company ยท US
Devilbiss Healthcare, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2026. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (2 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2026 | K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) Devilbiss Healthcare, LLC | CAW |
| Dec 9, 2025 | K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) Devilbiss Healthcare, LLC | CAW |
| Mar 23, 2018 | K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator Devilbiss Healthcare, LLC | CAW |
| Jan 21, 2016 | K152810 | DeVilbiss DV6WM Wireless Modem Devilbiss Healthcare, LLC | BZD |
| Sep 18, 2015 | K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE Devilbiss Healthcare, LLC | BZD |
| Aug 4, 2014 | K140880 | DEVILBISS SMARTLINK II SYSTEM Devilbiss Healthcare, LLC | BZD |
| Nov 22, 2011 | K112220 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL Devilbiss Healthcare, LLC | BZD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2023 | DeVilbiss Healthcare LLC DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR Open, Classified |
CAW | K071397 |
| Dec 19, 2022 | DeVilbiss Healthcare LLC DeVilbiss, 525 5-liter Oxygen Concentrator
Models 525DS, 525DS-Q Open, Classified |
CAW | K071397 |
| Nov 11, 2022 | DeVilbiss Healthcare LLC 125 series iGO2 Portable Oxygen Concentrator-indicated for the
administration of supplemental oxygen.
Models: 125D, 125D-XB Open, Classified |
CAW | K172648 |
| Jul 20, 2016 | DeVilbiss Healthcare LLC DeVilbiss Model 7305P-D Powered Suction Unit Terminated |
JCX | K982304 |
| Jul 1, 2014 | DeVilbiss Healthcare LLC DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. Terminated |
BZD | K071689 K091919 +1 |
| Oct 1, 2013 | DeVilbiss Healthcare LLC DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing Terminated |
JCX | K982304 |