Cleared Traditional

K950386 - MODEL 3200P/3200PR HYPERBARIC CHAMBER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950386 · Sechrist Industries, Inc. · Anesthesiology device
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Jun 1995
Decision
132d
Days
Class 2
Risk

K950386 is an FDA 510(k) clearance for the MODEL 3200P/3200PR HYPERBARIC CHAMBER. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 132 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.

View all Sechrist Industries, Inc. devices

Submission Details

510(k) Number K950386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date June 13, 1995
Days to Decision 132 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
7d faster than avg
Panel avg: 139d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.