Atlas FDA

CBF

69 FDA 510(k) clearances · Product code

154 daysmedian time to decision
399 days90th percentile
69clearances measured

FDA profile

Official device name
Chamber, Hyperbaric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5470
Medical specialty
Anesthesiology
Flags
Life-sustaining · Third-party review eligible
Adverse events (MAUDE)
2004: 2 · 2007: 2 · 2010: 11 · 2011: 5 · 2012: 9 · 2025: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (K240569)Fink Engineering Pty, Ltd.2024-11-21
Revitalair 430+ (K220290)Us Hyperbaric Network2023-05-04
Revitalair 430F (K171899)Oxavita Srl2019-11-22
OxyHeal 4000 Multiplace Hyperbaric Chamber Family (K163109)Oxyheal Medical Systems, Inc.2017-03-22
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (K152223)Oxyheal Medical Systems, Inc.2016-04-29
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K140559)Sechrist Industries, Inc.2014-05-30
RSI 4200 (K102831)Reimers Systems, Inc.2011-08-19
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (K092991)Environmental Tectonics Corp.2010-08-13
FLEXI-LITE (K101262)Pressure-Tech, Inc.2010-06-10
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K100268)Sechrist Industries, Inc.2010-04-26
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (K082455)Gulf Coast Hyperbarics, Inc.2009-05-22
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS (K081506)Hyperbaric America, LLC2008-07-25
SIGMA SERIES HYPERBARIC CHAMBER (K072427)Perry Baromedical Corp.2008-06-11
DIVE AND SHALLOW AND GRAND DIVE (K072757)Summit TO Sea2008-02-08
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 (K060739)Khrunichev State Research & Production Space Centr2006-07-21
HYPEROX 101 (K053498)Wjo, Inc.2006-03-15
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER (K052866)Oxyheal Health Group2005-12-13
FLEXI-LITE, MODEL FL-V1.2 (K051759)Performance Hyperbarics2005-11-17
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (K052713)Sechrist Industries, Inc.2005-10-28
ATA HCM MONOPLACE HYPERBARIC SYSTEM (K040145)Ata Hyperbaric Chamber Manufacturing2005-05-04
MILLENIUM, MODELS 2000, 2001 AND 2002 (K041007)Hyperbaric For Life, LLC2004-11-15
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM (K030418)Makai Marine Industries, Inc.2004-01-29
BAY AREA HYPERSCIENCES (K030713)Bay Area Hypersciences, LLC2003-12-19
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES (K031649)Fink Engineering Pty, Ltd.2003-12-05
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER (K022214)Mechidyne Systems, Inc.2003-02-26
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2 (K021689)Pan-America Hyperbarics, Inc.2002-10-24
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1 (K021693)Pan-America Hyperbarics, Inc.2002-10-24
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1 (K021690)Pan-America Hyperbarics, Inc.2002-10-24
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER (K020974)Environmental Tectonics Corp.2002-06-26
OXYGEN TREATMENT HOOD (K011592)Amron International Diving Supply, Inc.2002-06-19
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES (K011866)Hyperbaric Technologies, Inc.2002-06-06
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) (K001121)Engineered Medical Technology, Inc.2001-11-29
INFANT OXYGEN TREATMENT HOOD (K011565)Gulf Coast Hyperbarics, Inc.2001-08-16
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM (K011312)Khrunichev State Research & Production Space Centr2001-07-18
SEA-LONG MEDICAL TREATMENT HOOD (K010659)Sea-Long Medical Systems, Inc.2001-05-16
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS (K002795)Hypertec, Inc.2000-12-06
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY (K002794)Hypertec, Inc.2000-12-06
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER (K001409)Hyperbaric Technologies, Inc.2000-08-02
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER (K993010)Environmental Tectonics Corp.2000-05-30
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER (K990927)Perry Baromedical Corp.1999-11-12
HTU3 (K984313)Hyox Systems , Ltd.1999-10-22
TAMPA HYPERBARIC MONOPLACE CHAMBER (K981938)Tampa Hyperbaric Ent.1999-07-06
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM (K983648)Perry Baromedical Services1999-02-24
SANDS SERIES III HYPERBARIC CHAMBER (K972908)Sands Hyperbarics1998-07-22
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER (K974868)Perry Baromedical Corp.1998-07-02
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM (K952545)Wright Industries1997-05-28
HYPERBARIC CHAMBER (K960389)Tampa Hyperbaric Ent.1996-12-05
GSP1 - GAS SELECTION PANEL (K962869)Reimers Systems, Inc.1996-10-23
ODS1 - HOOD DRIVER (K962871)Reimers Systems, Inc.1996-10-23
LOUISVILLE LABS OXYGEN HEAD TENT (K955535)Louisville Laboratories, Inc.1996-07-01
SYSTEM ONE HYPERBARIC CHAMBER (K951044)Nth Systems, Inc.1996-01-25
T CLASS HYPERBARIC FACILITIES (K954387)Reimers Systems, Inc.1995-12-15
MODEL 3200P/3200PR HYPERBARIC CHAMBER (K950386)Sechrist Industries, Inc.1995-06-13
MODEL 2500E/2500ER HYPERBARIC CHAMBER (K934164)Sechrist Industries, Inc.1995-06-13
MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM (K950957)Gulf Coast Hyperbarics, Inc.1995-06-02
LIFEFORCE CLINICAL HYPERBARIC FACILITY (K951125)Reimers Systems, Inc.1995-06-02
LAB-SITE(R) SAFETY CANNULA (K933929)Migada, Ltd.1993-12-07
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER (K930748)Perry Baromedical Services1993-08-20
HYPERLITE (K905168)S.O.S. , Ltd.1991-07-22
GAMOW HYPERBARIC BAG (K874752)Hyperbaric Aerobics, Ltd.1988-02-02
H.T.U. (HYPERBARIC THERAPY UNIT) (K874107)Hyox Systems C/O Mechidyne Systems, Inc.1987-12-07
SIGMA II - DUAL PLACE HYPERBARIC CHAMBER (K862198)Perry Baromedical Services1986-11-12
HYPERBARIC PENETRATION EXTENSION SET (K861315)Cutter Laboratories, Inc.1986-05-21
SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION (K850563)Nautilus Environmedical Systems, Inc.1985-03-12
MICROSPAN -PH MONITOR (K842303)Biochem International, Inc.1984-10-12
RENEAU UNIT (K840841)Reneau, Inc.1984-08-07
MODEL 3000 HYPERBARIC CHAMBER (K841608)Custom Craft Products, Inc.1984-05-02
NAUTILUS MONOPLACE HYPERBARIC UNIT (K832127)Nautilus Environmedical Systems, Inc.1983-08-12
HYPERBARIC OXYGEN CHAMBER (K790693)Hyperbaric Oxygen Therapy, Inc.1979-07-30

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