Cleared Traditional

K031860 - SK MED ME202 MONITORING MIXER

K031860 is an FDA 510(k) clearance for SK MED ME202 MONITORING MIXER, manufactured by Sk Med. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K031860 · Sk Med · Anesthesiology device
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Jan 2004
Decision
219d
Days
Class 2
Risk

K031860 is an FDA 510(k) clearance for the SK MED ME202 MONITORING 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 January 21, 2004 after a review of 219 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 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.

FDA 510(k) Submission Details - K031860

510(k) Number K031860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date January 21, 2004
Days to Decision 219 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
79d slower than avg
Panel avg: 140d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K031860.
PRECISION BLENDER
K053232 · Precision Medical, Inc. · Jan 2006
PRAXAIR MEDICAL AIR MIXER
K051192 · Praxair, Inc. · Sep 2005
CS MEDICAL TTCF GAS DELIVERY SYSTEM
K050381 · Cs Medical, Inc. · Jul 2005
SK MED M201 PLUS MIXER
K031707 · Sk Med · Aug 2003
SK MED M201 MIXER
K022864 · Sk Med · Apr 2003
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · Mallard Medical, Inc. · Aug 2000
K031860 · SK MED ME202 MONITORING MIXER
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