Cleared Traditional

MCKESSON ANESTHESIA CARE (K113633) - FDA 510(k) Clearance

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

K113633 · Mckesson Technologies, Inc. · Anesthesiology device
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Apr 2012
Decision
134d
Days
Class 2
Risk

K113633 is an FDA 510(k) clearance for the MCKESSON ANESTHESIA CARE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Mckesson Technologies, Inc. (Philedelphia, US). The FDA issued a Cleared decision on April 20, 2012 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Mckesson Technologies, Inc. devices

Submission Details

510(k) Number K113633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2011
Decision Date April 20, 2012
Days to Decision 134 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
6d faster than avg
Panel avg: 140d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 33
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K113633.
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