Cleared Special

K052713 - MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052713 · Sechrist Industries, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Oct 2005
Decision
29d
Days
Class 2
Risk

K052713 is an FDA 510(k) clearance for the MODEL 3300E/ER 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 October 28, 2005 after a review of 29 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

Submission Details

510(k) Number K052713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date October 28, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 139d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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.