Cleared Traditional

K020974 - BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER

K020974 is an FDA 510(k) clearance for BARA-MED ACRYLIC MONOPLACE HYPERBARIC C..., manufactured by Environmental Tectonics Corp.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K020974 · Environmental Tectonics Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
92d
Days
Class 2
Risk

K020974 is an FDA 510(k) clearance for the BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Environmental Tectonics Corp. (Southampton, US). The FDA issued a Cleared decision on June 26, 2002 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K020974

510(k) Number K020974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 26, 2002
Decision Date June 26, 2002
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 140d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBF Chamber, Hyperbaric

All 56
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K020974.
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
K021689 · Pan-America Hyperbarics, Inc. · Oct 2002
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K021690 · Pan-America Hyperbarics, Inc. · Oct 2002
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
K021693 · Pan-America Hyperbarics, Inc. · Oct 2002
OXYGEN TREATMENT HOOD
K011592 · Amron International Diving Supply, Inc. · Jun 2002
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
K011866 · Hyperbaric Technologies, Inc. · Jun 2002
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121 · Engineered Medical Technology, Inc. · Nov 2001