Cleared Traditional

K950957 - MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM

K950957 is an FDA 510(k) clearance for MULTIPLACE HYPERBARIC TREATMENT CHAMBER..., manufactured by Gulf Coast Hyperbarics, Inc.. 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.

K950957 · Gulf Coast Hyperbarics, Inc. · Anesthesiology device
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Jun 1995
Decision
92d
Days
Class 2
Risk

K950957 is an FDA 510(k) clearance for the MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Gulf Coast Hyperbarics, Inc. (Panama City, US). The FDA issued a Cleared decision on June 2, 1995 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 - K950957

510(k) Number K950957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1995
Decision Date June 02, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 57
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K950957.
SYSTEM ONE HYPERBARIC CHAMBER
K951044 · Nth Systems, Inc. · Jan 1996
MODEL 2500E/2500ER HYPERBARIC CHAMBER
K934164 · Sechrist Industries, Inc. · Jun 1995
MODEL 3200P/3200PR HYPERBARIC CHAMBER
K950386 · Sechrist Industries, Inc. · Jun 1995
LAB-SITE(R) SAFETY CANNULA
K933929 · Migada, Ltd. · Dec 1993
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
K930748 · Perry Baromedical Services · Aug 1993
HYPERBARIC PENETRATION EXTENSION SET
K861315 · Cutter Laboratories, Inc. · May 1986