Cleared Traditional

K993010 - BARA-MED

K993010 is an FDA 510(k) clearance for BARA-MED, 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 266-day FDA review.

K993010 · Environmental Tectonics Corp. · Anesthesiology device
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May 2000
Decision
266d
Days
Class 2
Risk

K993010 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. (Washington, US). The FDA issued a Cleared decision on May 30, 2000 after a review of 266 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 Environmental Tectonics Corp. devices

FDA 510(k) Submission Details - K993010

510(k) Number K993010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1999
Decision Date May 30, 2000
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 140d · This submission: 266d
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 10
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K993010.
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K861315 · Cutter Laboratories, Inc. · May 1986