Cleared Traditional

K862198 - SIGMA II - DUAL PLACE HYPERBARIC CHAMBER

K862198 is an FDA 510(k) clearance for SIGMA II - DUAL PLACE 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 156-day FDA review.

K862198 · Perry Baromedical Services · Anesthesiology device
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Nov 1986
Decision
156d
Days
Class 2
Risk

K862198 is an FDA 510(k) clearance for the SIGMA II - DUAL PLACE HYPERBARIC CHAMBER. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Perry Baromedical Services (Great Neck, US). The FDA issued a Cleared decision on November 12, 1986 after a review of 156 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.

View all Perry Baromedical Services devices

FDA 510(k) Submission Details - K862198

510(k) Number K862198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1986
Decision Date November 12, 1986
Days to Decision 156 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 140d · This submission: 156d
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 23
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K862198.
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
HYPERBARIC PENETRATION EXTENSION SET
K861315 · Cutter Laboratories, Inc. · May 1986
MICROSPAN -PH MONITOR
K842303 · Biochem International, Inc. · Oct 1984