Cleared Special

K100268 - SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER

K100268 is an FDA 510(k) clearance for SECHRIST MONOPLACE HYPERBARIC OXYGEN CH..., manufactured by Sechrist Industries, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Special 510(k) pathway after a 87-day FDA review.

K100268 · Sechrist Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Apr 2010
Decision
87d
Days
Class 2
Risk

K100268 is an FDA 510(k) clearance for the SECHRIST MONOPLACE HYPERBARIC OXYGEN 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 April 26, 2010 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K100268

510(k) Number K100268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2010
Decision Date April 26, 2010
Days to Decision 87 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Modification to existing cleared device.

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 48
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K100268.
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