Cleared Abbreviated

K022864 - SK MED M201 MIXER

K022864 is an FDA 510(k) clearance for SK MED M201 MIXER, manufactured by Sk Med. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Abbreviated 510(k) pathway after a 226-day FDA review.

K022864 · Sk Med · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K022864

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 140d · This submission: 226d
Pathway characteristics
Standards-based clearance path.

BZR Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K022864.
CS MEDICAL TTCF GAS DELIVERY SYSTEM
K050381 · Cs Medical, Inc. · Jul 2005
SK MED ME202 MONITORING MIXER
K031860 · Sk Med · Jan 2004
SK MED M201 PLUS MIXER
K031707 · Sk Med · Aug 2003
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · Mallard Medical, Inc. · Aug 2000
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · Sechrist Industries, Inc. · Aug 1999
ALADDIN II MONITORING OXYGEN/AIR MONITOR
K990293 · Hamilton Medical, Inc. · Mar 1999
K022864 · SK MED M201 MIXER
Download PDF Sk Med