CBF · Class II · 21 CFR 868.5470

FDA Product Code CBF: Chamber, Hyperbaric

Leading manufacturers include Sechrist Industries, Inc., Perry Baromedical Corp. and Reimers Systems, Inc..

69
Total
69
Cleared
207d
Avg days
1979
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 266d recently vs 206d historically

FDA 510(k) Cleared Chamber, Hyperbaric Devices (Product Code CBF)

69 devices
1–24 of 69
Cleared Nov 21, 2024
FESL FINK Chamber
K240569
Fink Engineering Pty, Ltd.
Anesthesiology · 266d
Cleared May 04, 2023
Revitalair 430+
K220290
Us Hyperbaric Network
Anesthesiology · 457d
Cleared Nov 22, 2019
Revitalair 430F
K171899
Oxavita Srl
Anesthesiology · 879d
Cleared Mar 22, 2017
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
K163109
Oxyheal Medical Systems, Inc.
Anesthesiology · 135d
Cleared Apr 29, 2016
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
K152223
Oxyheal Medical Systems, Inc.
Anesthesiology · 266d
Cleared May 30, 2014
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K140559
Sechrist Industries, Inc.
Anesthesiology · 86d
Cleared Aug 19, 2011
RSI 4200
K102831
Reimers Systems, Inc.
Anesthesiology · 324d
Cleared Aug 13, 2010
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
K092991
Environmental Tectonics Corp.
Anesthesiology · 319d
Cleared Jun 10, 2010
FLEXI-LITE
K101262
Pressure-Tech, Inc.
Anesthesiology · 36d
Cleared Apr 26, 2010
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K100268
Sechrist Industries, Inc.
Anesthesiology · 87d
Cleared May 22, 2009
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
K082455
Gulf Coast Hyperbarics, Inc.
Anesthesiology · 269d
Cleared Jul 25, 2008
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
K081506
Hyperbaric America, LLC
Anesthesiology · 57d
Cleared Jun 11, 2008
SIGMA SERIES HYPERBARIC CHAMBER
K072427
Perry Baromedical Corp.
Anesthesiology · 287d
Cleared Feb 08, 2008
DIVE AND SHALLOW AND GRAND DIVE
K072757
Summit TO Sea
Anesthesiology · 134d
Cleared Jul 21, 2006
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
K060739
Khrunichev State Research & Production Space Centr
Anesthesiology · 123d
Cleared Mar 15, 2006
HYPEROX 101
K053498
Wjo, Inc.
Anesthesiology · 89d
Cleared Dec 13, 2005
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
K052866
Oxyheal Health Group
Anesthesiology · 63d
Cleared Nov 17, 2005
FLEXI-LITE, MODEL FL-V1.2
K051759
Performance Hyperbarics
Anesthesiology · 141d
Cleared Oct 28, 2005
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
K052713
Sechrist Industries, Inc.
Anesthesiology · 29d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
K021689
Pan-America Hyperbarics, Inc.
Anesthesiology · 154d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
K021690
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Oct 24, 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
K021693
Pan-America Hyperbarics, Inc.
Anesthesiology · 155d
Cleared Jun 26, 2002
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K020974
Environmental Tectonics Corp.
Anesthesiology · 92d
Cleared Jun 19, 2002
OXYGEN TREATMENT HOOD
K011592
Amron International Diving Supply, Inc.
Anesthesiology · 391d

About Product Code CBF - Regulatory Context

510(k) Submission Activity

69 total 510(k) submissions under product code CBF since 1979, with 69 receiving FDA clearance (average review time: 207 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - CBF Product Code

Recent submissions under CBF have taken an average of 266 days to reach a decision - up from 206 days historically. Manufacturers should account for longer review timelines in current project planning.

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