Product code CBF— Anesthesiology
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
- Classification name
- Chamber, Hyperbaric
- Device class
- Class 2
- Regulation
- 21 CFR 868.5470
- Advisory panel
- Anesthesiology
- Total cleared
- 69
- First cleared
- Most recent
Market context for product code CBF
FDA has cleared devices under product code CBF between 1979 and 2024, filed by 44 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2023
- 2019
- 2017
- 2016
- 2014
- 2011
- 2010
- 2009
- 2008
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code CBF
Adverse events under product code CBF
product code CBF- Death
- 6
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code CBF
- K240569 — FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
- K220290 — Revitalair 430+
- K171899 — Revitalair 430F
- K163109 — OxyHeal 4000 Multiplace Hyperbaric Chamber Family
- K152223 — Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
- K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
- K102831 — RSI 4200
- K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
- K101262 — FLEXI-LITE
- K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
- K082455 — RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
- K081506 — HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
- K072427 — SIGMA SERIES HYPERBARIC CHAMBER
- K072757 — DIVE AND SHALLOW AND GRAND DIVE
- K060739 — MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
- K053498 — HYPEROX 101
- K052866 — OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
- K051759 — FLEXI-LITE, MODEL FL-V1.2
- K052713 — MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
- K040145 — ATA HCM MONOPLACE HYPERBARIC SYSTEM
- K041007 — MILLENIUM, MODELS 2000, 2001 AND 2002
- K030418 — MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
- K030713 — BAY AREA HYPERSCIENCES
- K031649 — SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
- K022214 — MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
- K021689 — PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
- K021690 — PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
- K021693 — PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
- K020974 — BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
- K011592 — OXYGEN TREATMENT HOOD
- K011866 — OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
- K001121 — OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
- K011565 — INFANT OXYGEN TREATMENT HOOD
- K011312 — BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
- K010659 — SEA-LONG MEDICAL TREATMENT HOOD
- K002794 — MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
- K002795 — MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
- K001409 — GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
- K993010 — BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
- K990927 — SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
- K984313 — HTU3
- K981938 — TAMPA HYPERBARIC MONOPLACE CHAMBER
- K983648 — SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
- K972908 — SANDS SERIES III HYPERBARIC CHAMBER
- K974868 — SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
- K952545 — WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
- K960389 — HYPERBARIC CHAMBER
- K962869 — GSP1 - GAS SELECTION PANEL
- K962871 — ODS1 - HOOD DRIVER
- K955535 — LOUISVILLE LABS OXYGEN HEAD TENT
- K951044 — SYSTEM ONE HYPERBARIC CHAMBER
- K954387 — T CLASS HYPERBARIC FACILITIES
- K934164 — MODEL 2500E/2500ER HYPERBARIC CHAMBER
- K950386 — MODEL 3200P/3200PR HYPERBARIC CHAMBER
- K950957 — MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM
- K951125 — LIFEFORCE CLINICAL HYPERBARIC FACILITY
- K933929 — LAB-SITE(R) SAFETY CANNULA
- K930748 — SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
- K905168 — HYPERLITE
- K874752 — GAMOW HYPERBARIC BAG
- K874107 — H.T.U. (HYPERBARIC THERAPY UNIT)
- K862198 — SIGMA II - DUAL PLACE HYPERBARIC CHAMBER
- K861315 — HYPERBARIC PENETRATION EXTENSION SET
- K850563 — SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION
- K842303 — MICROSPAN -PH MONITOR
- K840841 — RENEAU UNIT
- K841608 — MODEL 3000 HYPERBARIC CHAMBER
- K832127 — NAUTILUS MONOPLACE HYPERBARIC UNIT
- K790693 — HYPERBARIC OXYGEN CHAMBER
Data sourced from openFDA. This site is unofficial and independent of the FDA.