Cleared Abbreviated

K022864 - SK MED M201 MIXER (FDA 510(k) Clearance)

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

K022864 · Sk Med · Anesthesiology device
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Apr 2003
Decision
226d
Days
Class 2
Risk

K022864 is an FDA 510(k) clearance for the SK MED M201 MIXER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Sk Med (Van Nuys, US). The FDA issued a Cleared decision on April 11, 2003 after a review of 226 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sk Med devices

Submission Details

510(k) Number K022864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2002
Decision Date April 11, 2003
Days to Decision 226 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 139d · This submission: 226d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 54
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