NFB · Class II · 21 CFR 868.5905

FDA Product Code NFB: Conserver, Oxygen

Leading manufacturers include Salter Labs, Puritan Bennett Corp. and Devilbiss Health Care, 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 Jul 21, 2004
EOCD
K041568
Respironics, Inc.
Anesthesiology · 41d
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 Mar 20, 2001
PM 1800 CONSERVING DEVICE
K001412
Precision Medical, Inc.
Anesthesiology · 320d
Cleared Oct 24, 2000
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284
Invacare Corp.
Anesthesiology · 90d
Cleared May 07, 1999
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678
Salter Labs
Anesthesiology · 66d
Cleared Oct 21, 1996
PULSE DOSE SERIES
K961126
Devilbiss Health Care, Inc.
Anesthesiology · 214d
Cleared Nov 22, 1995
MODEL IPD OXYGEN CONSERVING DEVICE
K953852
Invacare Corp.
Anesthesiology · 98d
Cleared Jul 24, 1989
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407
Salter Labs
Anesthesiology · 108d
Cleared Apr 06, 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141
Devilbiss Health Care, Inc.
Anesthesiology · 83d
Cleared Feb 23, 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298
Salter Labs
Anesthesiology · 35d
Cleared Dec 02, 1987
COMPANION MINI OXYGEN SAVER
K873901
Puritan Bennett Corp.
Anesthesiology · 69d
Cleared Oct 15, 1986
COMPANION OXYGEN SAVER
K863695
Puritan Bennett Corp.
Anesthesiology · 23d

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 →