Product Code: CBF FDA class 2 21 CFR 868.5470

Chamber, Hyperbaric

Anesthesiology

The Hyperbaric Chamber is an anesthesiology device that encloses a patient in an environment of elevated atmospheric pressure, allowing the breathing of pure oxygen or other gas mixtures at above-ambient pressure, used to treat conditions such as decompression sickness, carbon monoxide poisoning, and non-healing wounds. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBF, regulated under 21 CFR 868.5470, within the Anesthesiology medical specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CBF
Device Class: FDA class 2
Regulation Number: 868.5470
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 69 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240569	FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber	Nov 21, 2024	Substantially Equivalent	Fink Engineering Pty, Ltd.
K220290	Revitalair 430+	May 04, 2023	Substantially Equivalent	Us Hyperbaric Network
K171899	Revitalair 430F	Nov 22, 2019	Substantially Equivalent	Oxavita Srl
K163109	OxyHeal 4000 Multiplace Hyperbaric Chamber Family	Mar 22, 2017	Substantially Equivalent	Oxyheal Medical Systems, Inc.
K152223	Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System	Apr 29, 2016	Substantially Equivalent	Oxyheal Medical Systems, Inc.
K140559	SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER	May 30, 2014	Substantially Equivalent	Sechrist Industries, Inc.
K102831	RSI 4200	Aug 19, 2011	Substantially Equivalent	Reimers Systems, Inc.
K092991	O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)	Aug 13, 2010	Substantially Equivalent	Environmental Tectonics Corp.
K101262	FLEXI-LITE	Jun 10, 2010	Substantially Equivalent	Pressure-Tech, Inc.
K100268	SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER	Apr 26, 2010	Substantially Equivalent	Sechrist Industries, Inc.
K082455	RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER	May 22, 2009	Substantially Equivalent	Gulf Coast Hyperbarics, Inc.
K081506	HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS	Jul 25, 2008	Substantially Equivalent	Hyperbaric America, LLC
K072427	SIGMA SERIES HYPERBARIC CHAMBER	Jun 11, 2008	Substantially Equivalent	Perry Baromedical Corp.
K072757	DIVE AND SHALLOW AND GRAND DIVE	Feb 08, 2008	Substantially Equivalent	Summit TO Sea
K060739	MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307	Jul 21, 2006	Substantially Equivalent	Khrunichev State Research & Production Space Centr
K053498	HYPEROX 101	Mar 15, 2006	Substantially Equivalent	Wjo, Inc.
K052866	OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER	Dec 13, 2005	Substantially Equivalent	Oxyheal Health Group
K051759	FLEXI-LITE, MODEL FL-V1.2	Nov 17, 2005	Substantially Equivalent	Performance Hyperbarics
K052713	MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER	Oct 28, 2005	Substantially Equivalent	Sechrist Industries, Inc.
K040145	ATA HCM MONOPLACE HYPERBARIC SYSTEM	May 04, 2005	Substantially Equivalent	Ata Hyperbaric Chamber Manufacturing
K041007	MILLENIUM, MODELS 2000, 2001 AND 2002	Nov 15, 2004	Substantially Equivalent	Hyperbaric For Life, LLC
K030418	MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM	Jan 29, 2004	Substantially Equivalent	Makai Marine Industries, Inc.
K030713	BAY AREA HYPERSCIENCES	Dec 19, 2003	Substantially Equivalent	Bay Area Hypersciences, LLC
K031649	SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES	Dec 05, 2003	Substantially Equivalent	Fink Engineering Pty, Ltd.
K022214	MSI I2010 DUAL PLACE HYPERBARIC CHAMBER	Feb 26, 2003	Substantially Equivalent	Mechidyne Systems, Inc.
K021693	PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1	Oct 24, 2002	Substantially Equivalent	Pan-America Hyperbarics, Inc.
K021690	PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1	Oct 24, 2002	Substantially Equivalent	Pan-America Hyperbarics, Inc.
K021689	PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2	Oct 24, 2002	Substantially Equivalent	Pan-America Hyperbarics, Inc.
K020974	BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER	Jun 26, 2002	Unknown	Environmental Tectonics Corp.
K011592	OXYGEN TREATMENT HOOD	Jun 19, 2002	Substantially Equivalent	Amron International Diving Supply, Inc.
K011866	OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES	Jun 06, 2002	Substantially Equivalent	Hyperbaric Technologies, Inc.
K001121	OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)	Nov 29, 2001	Substantially Equivalent	Engineered Medical Technology, Inc.
K011565	INFANT OXYGEN TREATMENT HOOD	Aug 16, 2001	Substantially Equivalent	Gulf Coast Hyperbarics, Inc.
K011312	BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM	Jul 18, 2001	Substantially Equivalent	Khrunichev State Research & Production Space Centr
K010659	SEA-LONG MEDICAL TREATMENT HOOD	May 16, 2001	Substantially Equivalent	Sea-Long Medical Systems, Inc.
K002795	MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS	Dec 06, 2000	Substantially Equivalent	Hypertec, Inc.
K002794	MODEL 5000 MULTIPLACE HYPERBARIC THERAPY	Dec 06, 2000	Substantially Equivalent	Hypertec, Inc.
K001409	GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER	Aug 02, 2000	Substantially Equivalent	Hyperbaric Technologies, Inc.
K993010	BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER	May 30, 2000	Substantially Equivalent	Environmental Tectonics Corp.
K990927	SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER	Nov 12, 1999	Substantially Equivalent	Perry Baromedical Corp.
K984313	HTU3	Oct 22, 1999	Substantially Equivalent	Hyox Systems , Ltd.
K981938	TAMPA HYPERBARIC MONOPLACE CHAMBER	Jul 06, 1999	Substantially Equivalent	Tampa Hyperbaric Ent.
K983648	SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM	Feb 24, 1999	Substantially Equivalent	Perry Baromedical Services
K972908	SANDS SERIES III HYPERBARIC CHAMBER	Jul 22, 1998	Substantially Equivalent	Sands Hyperbarics
K974868	SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER	Jul 02, 1998	Substantially Equivalent	Perry Baromedical Corp.
K952545	WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM	May 28, 1997	Substantially Equivalent	Wright Industries
K960389	HYPERBARIC CHAMBER	Dec 05, 1996	Substantially Equivalent	Tampa Hyperbaric Ent.
K962871	ODS1 - HOOD DRIVER	Oct 23, 1996	Substantially Equivalent	Reimers Systems, Inc.
K962869	GSP1 - GAS SELECTION PANEL	Oct 23, 1996	Substantially Equivalent	Reimers Systems, Inc.
K955535	LOUISVILLE LABS OXYGEN HEAD TENT	Jul 01, 1996	Substantially Equivalent	Louisville Laboratories, Inc.
K951044	SYSTEM ONE HYPERBARIC CHAMBER	Jan 25, 1996	Substantially Equivalent	Nth Systems, Inc.
K954387	T CLASS HYPERBARIC FACILITIES	Dec 15, 1995	Substantially Equivalent	Reimers Systems, Inc.
K950386	MODEL 3200P/3200PR HYPERBARIC CHAMBER	Jun 13, 1995	Substantially Equivalent	Sechrist Industries, Inc.
K934164	MODEL 2500E/2500ER HYPERBARIC CHAMBER	Jun 13, 1995	Substantially Equivalent	Sechrist Industries, Inc.
K951125	LIFEFORCE CLINICAL HYPERBARIC FACILITY	Jun 02, 1995	Substantially Equivalent	Reimers Systems, Inc.
K950957	MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM	Jun 02, 1995	Substantially Equivalent	Gulf Coast Hyperbarics, Inc.
K933929	LAB-SITE(R) SAFETY CANNULA	Dec 07, 1993	Substantially Equivalent	Migada, Ltd.
K930748	SIGMA MP MULTIPLACE HYPERBARIC CHAMBER	Aug 20, 1993	Substantially Equivalent	Perry Baromedical Services
K905168	HYPERLITE	Jul 22, 1991	Substantially Equivalent	S.O.S. , Ltd.
K874752	GAMOW HYPERBARIC BAG	Feb 02, 1988	Substantially Equivalent	Hyperbaric Aerobics, Ltd.
K874107	H.T.U. (HYPERBARIC THERAPY UNIT)	Dec 07, 1987	Substantially Equivalent	Hyox Systems C/O Mechidyne Systems, Inc.
K862198	SIGMA II - DUAL PLACE HYPERBARIC CHAMBER	Nov 12, 1986	Substantially Equivalent	Perry Baromedical Services
K861315	HYPERBARIC PENETRATION EXTENSION SET	May 21, 1986	Substantially Equivalent	Cutter Laboratories, Inc.
K850563	SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION	Mar 12, 1985	Substantially Equivalent	Nautilus Environmedical Systems, Inc.
K842303	MICROSPAN -PH MONITOR	Oct 12, 1984	Substantially Equivalent	Biochem International, Inc.
K840841	RENEAU UNIT	Aug 07, 1984	Substantially Equivalent	Reneau, Inc.
K841608	MODEL 3000 HYPERBARIC CHAMBER	May 02, 1984	Substantially Equivalent	Custom Craft Products, Inc.
K832127	NAUTILUS MONOPLACE HYPERBARIC UNIT	Aug 12, 1983	Substantially Equivalent	Nautilus Environmedical Systems, Inc.
K790693	HYPERBARIC OXYGEN CHAMBER	Jul 30, 1979	Substantially Equivalent	Hyperbaric Oxygen Therapy, Inc.