Devilbiss Healthcare, LLC
Devilbiss Healthcare, LLC holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2026, with 6 FDA device recalls on record.
Top product codes for Devilbiss Healthcare, LLC
FDA recalls by Devilbiss Healthcare, LLC
- Z-1558-2023 — DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR
- Z-0724-2023 — DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q
- Z-0229-2023 — 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
- Z-2246-2016 — DeVilbiss Model 7305P-D Powered Suction Unit
- Z-1949-2014 — 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.
- Z-2319-2013 — 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, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Devilbiss Healthcare, LLC
- K253549 — DeVilbiss 5 Liter Oxygen Concentrator (555)
- K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
- K172648 — Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
- K152810 — DeVilbiss DV6WM Wireless Modem
- K143677 — DeVilbiss Intellipap2/DeVilbiss BLUE
- K140880 — DEVILBISS SMARTLINK II SYSTEM
- K112220 — DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.