Cleared Special

K031707 - SK MED M201 PLUS MIXER

K031707 is an FDA 510(k) clearance for SK MED M201 PLUS MIXER, manufactured by Sk Med. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Special 510(k) pathway after a 60-day FDA review.

K031707 · Sk Med · Anesthesiology device
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Aug 2003
Decision
60d
Days
Class 2
Risk

K031707 is an FDA 510(k) clearance for the SK MED M201 PLUS 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 August 1, 2003 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031707

510(k) Number K031707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date August 01, 2003
Days to Decision 60 days
Submission Type Special
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
80d faster than avg
Panel avg: 140d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

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 K031707.
PRAXAIR MEDICAL AIR MIXER
K051192 · Praxair, Inc. · Sep 2005
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 MIXER
K022864 · Sk Med · Apr 2003
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · Mallard Medical, Inc. · Aug 2000
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · Sechrist Industries, Inc. · Aug 1999
K031707 · SK MED M201 PLUS MIXER
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