Cleared Traditional

K092991 - O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (FDA 510(k) Clearance)

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

K092991 · Environmental Tectonics Corp. · Anesthesiology device
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Aug 2010
Decision
319d
Days
Class 2
Risk

K092991 is an FDA 510(k) clearance for the O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING). Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Environmental Tectonics Corp. (Southampton, US). The FDA issued a Cleared decision on August 13, 2010 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K092991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date August 13, 2010
Days to Decision 319 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 139d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.