Conserver, Oxygen
Anesthesiology · 21 CFR 868.5905
Recent MDR events
55 adverse event reports on file
- AIRLIFE¿Feb 17, 2026MalfunctionVyaire Medical, Inc.24364142
- AIRLIFEJan 23, 2026InjurySalter Labs3004748541-2026-00018
- AIRLIFEJan 2, 2026MalfunctionSalter Labs3004748541-2026-00004
- AIRLIFE¿Dec 5, 2025MalfunctionVyaire Medical, Inc.23728492
- AIRLIFENov 19, 2025InjurySalter Labs De Mexico De S.a. De C.v.3004748541-2025-00124
- AIRLIFENov 19, 2025InjurySalter Labs De Mexico De S.a. De C.v.3004748541-2025-00125
- AIRLIFENov 19, 2025InjurySalter Labs De Mexico De S.a. De C.v.3004748541-2025-00123
- AIRLIFE¿Oct 20, 2025MalfunctionVyaire Medical, Inc.23335307
- OXYGEN E CYLINDERAug 6, 2025InjuryUnknownMW5174151
- AIRLIFEJul 18, 2025InjuryAirlife1314417-2025-00049
Event type breakdown
Recalls
6 recall events for this product code
- Invacare CorporationTerminatedAug 8, 2016
lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton.
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Z-2364-2016 · View FDA record ↗ - Invacare CorporationTerminatedAug 8, 2016
Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton.
The rear gradation scale was screen printed upside down on the flowmeter gauge.
Z-2365-2016 · View FDA record ↗ - Superior Products IncTerminatedJan 23, 2008
Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products, Inc/SP Medical, LLC, Cleveland, Ohio 44144
Leakage: Device was leaking oxygen
Z-0529-2008 · View FDA record ↗ - Sunrise MedicalTerminatedApr 21, 2007
DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
Cylinder could lose oxygen at high pressure after the filling process
Z-0731-2007 · View FDA record ↗ - Sunrise MedicalTerminatedApr 21, 2007
535D-X CF Continuous Flow Cylinder
Cylinder could lose oxygen at high pressure after the filling process
Z-0732-2007 · View FDA record ↗ - Inovo, IncTerminatedUnknown
Inovo Single Luman Conserver
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Z-2099-2019 · View FDA record ↗
Registered firms
30 firms currently registered for this product code
Inovo Inc.
Lehigh Acres, FL, US
Caire Inc.
Ball Ground, GA, US
Compass Health Brands (corporate Office)
Middleburg Heights, OH, US
Responsive Respiratory Inc.
Saint Louis, MO, US
Salter Labs De Mexico De S.a. De C.v.
Chihuahua Mexico, MX
Vincent Medical (dong Guan) Manufacturing Co., Ltd.
Dong Guan City Guangdong, CN
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Cbr Enterprise Limited
Hong Kong, HK
Incoba Llc Dba Dynaris
Chesterfield, MO, US
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Vincent Medical Manufacturing. Co., Ltd.
KOWLOON, HK
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Allied Medical Llc
Earth City, MO, US
Caire Inc.
Ball Ground, GA, US
Dynasthetics
Salt Lake City, UT, US
Salter Labs
El Paso, TX, US
510(k) clearances
71 clearances for this product code
- Responsive RespiratoryJul 24, 2025
K250322 · Respond OC Conserving Regulator (130-0800)
- Dynasthetics, LLCDec 15, 2022
K220591 · Proxima
- Effortless Oxygen, LLCOct 17, 2022
K221014 · Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
- Incoba Ltd D/B/A DynarisNov 14, 2020
K200401 · Apogee
- Salter LabsMar 11, 2016
K151506 · Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- Medical Products, LLCOct 11, 2013
K131023 · THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
- Inovo, Inc.Dec 8, 2011
K113111 · CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
- Inovo, Inc.Dec 17, 2010
K103392 · CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER