NFB · Conserver, Oxygen
Anesthesiology · 21 CFR 868.5905 · Class 2
Overview
| Product Code | NFB |
|---|---|
| Device Name | Conserver, Oxygen |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250322 | Respond OC Conserving Regulator (130-0800) | Responsive Respiratory | Jul 24, 2025 | SESE |
| K220591 | Proxima | Dynasthetics, LLC | Dec 15, 2022 | SESE |
| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile | Effortless Oxygen, LLC | Oct 17, 2022 | SESE |
| K200401 | Apogee | Incoba Ltd D/B/A Dynaris | Nov 14, 2020 | SESE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | Salter Labs | Mar 11, 2016 | SESE |
| K131023 | THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN | Medical Products, LLC | Oct 11, 2013 | SESE |
| K113111 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION | Inovo, Inc. | Dec 8, 2011 | SESE |
| K103392 | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER | Inovo, Inc. | Dec 17, 2010 | SESE |
| K090421 | MODEL 350G GAS CONSERVER | Inspired Technologies, Inc. | May 29, 2009 | SESE |
| K070740 | CHAD THERAPEUTICS BONSAI MODEL 800 | Chad Therapeutics, Inc. | May 7, 2007 | SESE |
| K060751 | INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR | Inovo, Inc. | Jul 18, 2006 | SESE |
| K060382 | FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1 | Ameriflo Corp. | Apr 19, 2006 | SESE |
| K052563 | INOGEN SATELLITE CONSERVER, MODEL SC-100 | Medical Electronic Devices, Inc. | Oct 24, 2005 | SESE |
| K051988 | OXY-SERVE II OXYGEN CONSERVING REGULATOR | Superior Products, Inc. | Sep 21, 2005 | SESE |
| K051540 | INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR | Inovo, Inc. | Sep 21, 2005 | SESE |
| K051007 | ACCU02 SYSTEM | Miti Corp. | Jun 16, 2005 | SESE |
| K042142 | CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S | Chad Therapeutics, Inc. | Sep 20, 2004 | SESE |
| K041057 | FLO-RITE | Ameriflo Corp. | Aug 12, 2004 | SESE |
| K041568 | EOCD | Respironics, Inc. | Jul 21, 2004 | SESE |
| K033197 | INOGEN SATELLITE CONSERVER | Medical Electronic Devices, Inc. | May 13, 2004 | SESE |
Top Applicants
- Chad Therapeutics, Inc. — 11 clearances
- Inovo, Inc. — 5 clearances
- Medical Electronic Devices, Inc. — 5 clearances
- Salter Labs — 4 clearances
- Airsep Corp. — 2 clearances
