Conserver, Oxygen
FDA product code NFB · Class II (moderate risk) · 21 CFR 868.5905 · Anesthesiology
71510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Chad Therapeutics, Inc. 11
- Medical Electronic Devices, Inc. 5
- Inovo, Inc. 5
- Salter Labs 4
- Puritan Bennett Corp. 2
- The John Bunn Co. 2
- Precision Medical, Inc. 2
- Thermadyne Holings Corp. 2
- Ameriflo Corp. 2
- Devilbiss Health Care, Inc. 2
- Transtracheal Systems 2
- Airsep Corp. 2
- Contemporary Products, Inc. 2
- Invacare Corp. 2
- Applied Membrane Technology, Inc. 1
- B & F Medical Products, Inc. 1
- Responsive Respiratory, Inc. 1
- The Henry G. Dietz Co., Inc. 1
- Jones Sales Co. 1
- Smith-Perry Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250322 | Respond OC Conserving Regulator (130-0800)NFB · Traditional | Responsive Respiratory | 07/24/2025SE |
| K220591 | ProximaNFB · Traditional | Dynasthetics, LLC | 12/15/2022SE |
| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileNFB · Traditional | Effortless Oxygen, LLC | 10/17/2022SE |
| K200401 | ApogeeNFB · Traditional | Incoba Ltd D/B/A Dynaris | 11/14/2020SE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional | Salter Labs | 03/11/2016SE |
| K131023 | Theraflow Single Lumen and Theraflow Dual LumenNFB · Traditional | Medical Products, LLC | 10/11/2013SE |
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | Inovo, Inc. | 12/08/2011SE |
| K103392 | Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special | Inovo, Inc. | 12/17/2010SE |
| K090421 | Model 350G Gas ConserverNFB · Traditional | Inspired Technologies, Inc. | 05/29/2009SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | Chad Therapeutics, Inc. | 05/07/2007SE |
| K060751 | Inovo, Inc. Accupulse Single Lumen Conserving RegulatorNFB · Traditional | Inovo, Inc. | 07/18/2006SE |
| K060382 | Flo-Rite, Model 478-1; Flo-Rite II, Model 478-1; Simpulse II, Model 478-2S; Numatix…NFB · Special | Ameriflo Corp. | 04/19/2006SE |
| K052563 | Inogen Satellite Conserver, Model SC-100NFB · Traditional | Medical Electronic Devices, Inc. | 10/24/2005SE |
| K051988 | Oxy-Serve II Oxygen Conserving RegulatorNFB · Traditional | Superior Products, Inc. | 09/21/2005SE |
| K051540 | Inovo, Inc. Independence Oxygen Conserving RegulatorNFB · Traditional | Inovo, Inc. | 09/21/2005SE |
| K051007 | ACCU02 SystemNFB · Traditional | Miti Corp. | 06/16/2005SE |
| K042142 | Chad Therapeutics Lotus, Models OM-700 and OM-700SNFB · Special | Chad Therapeutics, Inc. | 09/20/2004SE |
| K041057 | Flo-RiteNFB · Traditional | Ameriflo Corp. | 08/12/2004SE |
| K041568 | EocdNFB · Abbreviated | Respironics, Inc. | 07/21/2004SE |
| K033197 | Inogen Satellite ConserverNFB · Traditional | Medical Electronic Devices, Inc. | 05/13/2004SE |
| K033364 | Chad Therapeutics SageNFB · Traditional | Chad Therapeutics, Inc. | 05/11/2004SE |
| K024023 | Essex High Pressure (HP) Ocd and Essex Escort Pneumatic ConserverNFB · Traditional | Essex Medical Systems Plus | 10/01/2003SE |
| K031983 | Inovo, Inc, Economizer Conserving RegulatorNFB · Traditional | Inovo, Inc. | 09/15/2003SE |
| K032018 | Easy Pulse II Oxygen ConserverNFB · Traditional | Precision Medical, Inc. | 08/25/2003SE |
| K023673 | Airlife Demand Nasal CannulaNFB · Traditional | Allegiance Healthcare Corp. | 05/02/2003SE |
| K022865 | 6203NFB · Traditional | Contemporary Products, Inc. | 02/13/2003SE |
| K023420 | Pulsed Oxygen Conserving Device - Every Breath, Pocdeb, ReactebNFB · Special | Medical Electronic Devices, Inc. | 10/25/2002SE |
| K020475 | Chad Therapeutics Oxypenumatic Cypress Model 511NFB · Traditional | Chad Therapeutics, Inc. | 07/05/2002SE |
| K020329 | Devilbiss PD1000NFB · Traditional | Sunrise Medical Hhg, Inc. | 06/19/2002SE |
| K010747 | Opc Oxygen Conserving Regulator, Model Ahg 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830NFB · Traditional | Western Ent. | 05/16/2001SE |
| K010389 | Chad Therapeutics Oxymatic Model 401 and Oxymatic Model 411NFB · Special | Chad Therapeutics, Inc. | 03/23/2001SE |
| K001412 | PM 1800 Conserving DeviceNFB · Abbreviated | Precision Medical, Inc. | 03/20/2001SE |
| K003455 | Modification to Chad Therapeutics Oxymatic Model 401NFB · Special | Chad Therapeutics, Inc. | 12/06/2000SE |
| K002284 | Venture Idd Oxygen Conserving Device Idd 20EX and 50EXNFB · Traditional | Invacare Corp. | 10/24/2000SE |
| K001579 | Impulse SelectNFB · Traditional | Airsep Corp. | 08/31/2000SE |
| K992935 | OCD2001NFB · Abbreviated | Contemporary Products, Inc. | 06/20/2000SE |
| K000890 | Chad Therapeutics Oxymatic Model 401NFB · Traditional | Chad Therapeutics, Inc. | 06/16/2000SE |
| K992659 | O2N Demand-Ii, Victor Model Ocpr-IiNFB · Special | Thermadyne Holings Corp. | 09/03/1999SE |
| K982943 | Transtracheal Demand Oxygen Controller Model DOC-3000NFB · Traditional | Transtracheal Systems | 07/12/1999SE |
| K990678 | Pneumatic Demand Oxygen Conserver (Pdoc)NFB · Traditional | Salter Labs | 05/07/1999SE |
| K983601 | Demand Oxygen Conserving Device, Docd, the DocNFB · Traditional | Medical Electronic Devices, Inc. | 12/15/1998SE |
| K983459 | Pulsed Oxygen Conserving Device, PocdNFB · Traditional | Medical Electronic Devices, Inc. | 12/08/1998SE |
| K964541 | Sanpo INFB · Traditional | Koike Medical Co. | 09/26/1997SE |
| K970371 | Flotec Oxysavrr (S)NFB · Traditional | Flotec, Inc. | 07/10/1997SE |
| K963247 | Victor Model Ocpr Oxygen Conserving Pressure RegulatorNFB · Traditional | Thermadyne Holings Corp. | 11/07/1996SE |
| K962944 | Transtracheal Demand Oxygen Controller (DOC-2000)NFB · Traditional | Transtracheal Systems | 10/23/1996SE |
| K961126 | Pulse Dose SeriesNFB · Traditional | Devilbiss Health Care, Inc. | 10/21/1996SE |
| K962766 | Airsep ImpulseNFB · Traditional | Airsep Corp. | 10/10/1996SE |
| K955129 | Oxypulse Eoc I, Eoc II & Eoc RNFB · Traditional | Eagle Medical Equipment Co. | 02/16/1996SE |
| K953852 | Model Ipd Oxygen Conserving DeviceNFB · Traditional | Invacare Corp. | 11/22/1995SE |
| K923660 | Medisonic Oxygen Flow ControllerNFB · Traditional | Medisonic U.S.A., Inc. | 01/27/1993SE |
| K903504 | Hala'Tus 1 OxygenatorNFB · Traditional | The Henry G. Dietz Co., Inc. | 01/28/1991SE |
| K892639 | The Original Pulse-PakNFB · Traditional | Jones Sales Co. | 10/05/1989SE |
| K892407 | Modified Demand Nasal Oxygen CannulaNFB · Traditional | Salter Labs | 07/24/1989SE |
| K890141 | Devilbiss Model 1400D (Oxygen Conserving Device)NFB · Traditional | Devilbiss Health Care, Inc. | 04/06/1989SE |
| K890298 | Demand Nasal Oxygen Cannula Models 4008/4108/4208NFB · Traditional | Salter Labs | 02/23/1989SE |
| K884562 | OXYMATIC-24NFB · Traditional | Chad Therapeutics, Inc. | 01/09/1989SE |
| K884754 | Voyager/XNFB · Traditional | Smith-Perry Corp. | 01/04/1989SE |
| K883590 | OxytrolNFB · Traditional | Cryogenic Assoc. | 11/02/1988SE |
| K883216 | Bunn Model 50 Oxygen Flow ControllerNFB · Traditional | The John Bunn Co. | 08/18/1988SE |
| K874804 | Oxygen Supply Control Regulator (Oscr)NFB · Traditional | Transamerica Products, Inc. | 02/11/1988SE |
| K873901 | Companion Mini Oxygen SaverNFB · Traditional | Puritan Bennett Corp. | 12/02/1987SE |
| K864127 | Mechanical Oxygen RegulatorNFB · Traditional | Travomed, Inc. | 11/13/1986SE |
| K863695 | Companion Oxygen SaverNFB · Traditional | Puritan Bennett Corp. | 10/15/1986SE |
| K861325 | Maxi-Use O2 DeviceNFB · Traditional | B & F Medical Products, Inc. | 09/09/1986SE |
| K861199 | Bunn Model 22 Oxygen Flow ControllerNFB · Traditional | The John Bunn Co. | 08/26/1986SE |
| K853378 | Auto ProNFB · Traditional | Respiration Technology, Inc. | 09/19/1985SE |
| K852650 | Oxymatictm Electronic Oxgyen ConserverNFB · Traditional | Chad Therapeutics, Inc. | 08/13/1985SE |
| K851235 | Demand Oxygen Sauer DOS2 Model 10NFB · Traditional | Applied Membrane Technology, Inc. | 04/30/1985SE |
| K834588 | Oxymizer-PendantNFB · Traditional | Chad Therapeutics, Inc. | 03/19/1984SE |
| K830009 | OxymizerNFB · Traditional | Chad Therapeutics, Inc. | 04/02/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2099-2019 Class II | Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow…The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak. | Inovo, Inc | 04/26/2019Terminated |
| Z-2365-2016 Class II | 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. | Invacare Corporation | 06/21/2016Terminated |
| Z-2364-2016 Class II | 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. | Invacare Corporation | 06/21/2016Terminated |
| Z-0529-2008 | Oxy Serve II Oxygen Conserving Regulator, Model Number: MCRB-870-6, Superior Products…Leakage: Device was leaking oxygen | Superior Products Inc | 10/19/2007Terminated |
| Z-0732-2007 | 535D-X CF Continuous Flow CylinderCylinder could lose oxygen at high pressure after the filling process | Sunrise Medical | 01/24/2007Terminated |
| Z-0731-2007 | DeVilbiss PD1000A Pulse Dose Oxygen Conserving CylinderCylinder could lose oxygen at high pressure after the filling process | Sunrise Medical | 01/24/2007Terminated |