Cleared Traditional

K942799 - DATUM

K942799 is an FDA 510(k) clearance for DATUM, manufactured by Blease USA, Inc.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K942799 · Blease USA, Inc. · Anesthesiology device
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Apr 1995
Decision
302d
Days
Class 2
Risk

K942799 is an FDA 510(k) clearance for the DATUM. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Blease USA, Inc. (Lynnwood, US). The FDA issued a Cleared decision on April 13, 1995 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - 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.

FDA 510(k) Submission Details - K942799

510(k) Number K942799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1994
Decision Date April 13, 1995
Days to Decision 302 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 140d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 - CAD Vaporizer, Anesthesia, Non-heated

All 41
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K942799.
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