Medical Device Manufacturer · US , Somerset , PA

Devilbiss Healthcare, LLC - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2011

Recent clearances: DeVilbiss 5 Liter Oxygen Concentrator (555), DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW), Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Devilbiss Healthcare, LLC Anesthesiology ✕

7 devices
1-7 of 7
Cleared Mar 26, 2026
DeVilbiss 5 Liter Oxygen Concentrator (555)
K253549 · CAW
Anesthesiology · 132d
Cleared Dec 09, 2025
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
K250805 · CAW
Anesthesiology · 267d
Cleared Mar 23, 2018
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
K172648 · CAW
Anesthesiology · 203d
Cleared Jan 21, 2016
DeVilbiss DV6WM Wireless Modem
K152810 · BZD
Anesthesiology · 115d
Cleared Sep 18, 2015
DeVilbiss Intellipap2/DeVilbiss BLUE
K143677 · BZD
Anesthesiology · 268d
Cleared Aug 04, 2014
DEVILBISS SMARTLINK II SYSTEM
K140880 · BZD
Anesthesiology · 119d
Cleared Nov 22, 2011
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
K112220 · BZD
Anesthesiology · 112d
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