NFB · Class II · 21 CFR 868.5905

FDA Product Code NFB: Conserver, Oxygen

Leading manufacturers include Chad Therapeutics, Inc., Salter Labs and Inovo, Inc..

71
Total
71
Cleared
116d
Avg days
1983
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 170d recently vs 116d historically

FDA 510(k) Cleared Conserver, Oxygen Devices (Product Code NFB)

71 devices
1–24 of 71
Cleared Jul 24, 2025
Respond OC Conserving Regulator (130-0800)
K250322
Responsive Respiratory
Anesthesiology · 170d
Cleared Dec 15, 2022
Proxima
K220591
Dynasthetics, LLC
Anesthesiology · 289d
Cleared Oct 17, 2022
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K221014
Effortless Oxygen, LLC
Anesthesiology · 195d
Cleared Nov 14, 2020
Apogee
K200401
Incoba Ltd D/B/A Dynaris
Anesthesiology · 270d
Cleared Mar 11, 2016
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K151506
Salter Labs
Anesthesiology · 281d
Cleared Oct 11, 2013
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
K131023
Medical Products, LLC
Anesthesiology · 182d
Cleared Dec 08, 2011
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
K113111
Inovo, Inc.
Anesthesiology · 49d
Cleared Dec 17, 2010
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
K103392
Inovo, Inc.
Anesthesiology · 28d
Cleared May 29, 2009
MODEL 350G GAS CONSERVER
K090421
Inspired Technologies, Inc.
Anesthesiology · 100d
Cleared May 07, 2007
CHAD THERAPEUTICS BONSAI MODEL 800
K070740
Chad Therapeutics, Inc.
Anesthesiology · 52d
Cleared Jul 18, 2006
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
K060751
Inovo, Inc.
Anesthesiology · 119d
Cleared Apr 19, 2006
FLO-RITE, MODEL 478-1
K060382
Ameriflo Corp.
Anesthesiology · 64d
Cleared Oct 24, 2005
INOGEN SATELLITE CONSERVER, MODEL SC-100
K052563
Medical Electronic Devices, Inc.
Anesthesiology · 35d
Cleared Sep 21, 2005
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
K051540
Inovo, Inc.
Anesthesiology · 103d
Cleared Sep 21, 2005
OXY-SERVE II OXYGEN CONSERVING REGULATOR
K051988
Superior Products, Inc.
Anesthesiology · 61d
Cleared Jun 16, 2005
ACCU02 SYSTEM
K051007
Miti Corp.
Anesthesiology · 57d
Cleared Sep 20, 2004
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
K042142
Chad Therapeutics, Inc.
Anesthesiology · 42d
Cleared Aug 12, 2004
FLO-RITE
K041057
Ameriflo Corp.
Anesthesiology · 111d
Cleared Jul 21, 2004
EOCD
K041568
Respironics, Inc.
Anesthesiology · 41d
Cleared May 11, 2004
CHAD THERAPEUTICS SAGE
K033364
Chad Therapeutics, Inc.
Anesthesiology · 203d
Cleared Aug 25, 2003
EASY PULSE II OXYGEN CONSERVER
K032018
Precision Medical, Inc.
Anesthesiology · 56d
Cleared May 02, 2003
AIRLIFE DEMAND NASAL CANNULA
K023673
Allegiance Healthcare Corp.
Anesthesiology · 182d
Cleared Jul 05, 2002
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475
Chad Therapeutics, Inc.
Anesthesiology · 143d
Cleared Jun 19, 2002
DEVILBISS PD1000
K020329
Sunrise Medical Hhg, Inc.
Anesthesiology · 139d

About Product Code NFB - Regulatory Context

510(k) Submission Activity

71 total 510(k) submissions under product code NFB since 1983, with 71 receiving FDA clearance (average review time: 116 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - NFB Product Code

Recent submissions under NFB have taken an average of 170 days to reach a decision - up from 116 days historically. Manufacturers should account for longer review timelines in current project planning.

NFB devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →