Cleared Traditional

K930748 - SIGMA MP MULTIPLACE HYPERBARIC CHAMBER

K930748 is an FDA 510(k) clearance for SIGMA MP MULTIPLACE HYPERBARIC CHAMBER, manufactured by Perry Baromedical Services. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K930748 · Perry Baromedical Services · Anesthesiology device
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Aug 1993
Decision
189d
Days
Class 2
Risk

K930748 is an FDA 510(k) clearance for the SIGMA MP MULTIPLACE HYPERBARIC CHAMBER. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Perry Baromedical Services (Riviera Beach, US). The FDA issued a Cleared decision on August 20, 1993 after a review of 189 days - an extended review cycle.

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 - K930748

510(k) Number K930748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1993
Decision Date August 20, 1993
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
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 68
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K930748.
MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM
K950957 · Gulf Coast Hyperbarics, Inc. · Jun 1995
LIFEFORCE CLINICAL HYPERBARIC FACILITY
K951125 · Reimers Systems, Inc. · Jun 1995
LAB-SITE(R) SAFETY CANNULA
K933929 · Migada, Ltd. · Dec 1993
HYPERLITE
K905168 · S.O.S. , Ltd. · Jul 1991
GAMOW HYPERBARIC BAG
K874752 · Hyperbaric Aerobics, Ltd. · Feb 1988
H.T.U. (HYPERBARIC THERAPY UNIT)
K874107 · Hyox Systems C/O Mechidyne Systems, Inc. · Dec 1987
K930748 · SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
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