Cleared Traditional

K860373 - THE M100 AIR/OXYGEN MIXER

K860373 is an FDA 510(k) clearance for THE M100 AIR/OXYGEN MIXER, manufactured by Newport Medical Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K860373 · Newport Medical Instruments, Inc. · Anesthesiology device
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May 1986
Decision
107d
Days
Class 2
Risk

K860373 is an FDA 510(k) clearance for the THE M100 AIR/OXYGEN MIXER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Newport Medical Instruments, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on May 21, 1986 after a review of 107 days - within the typical 510(k) review window.

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.

View all Newport Medical Instruments, Inc. devices

FDA 510(k) Submission Details - K860373

510(k) Number K860373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1986
Decision Date May 21, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
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 24
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K860373.
BIRD MICROBLENDER M.R.I.
K895695 · Bird Products Corp. · Jul 1990
P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER
K883038 · Bird Products Corp. · Nov 1988
SIEMENS O2-AIR MIXER 965
K872278 · Siemens Elema AB · Sep 1987
OHMEDA OXYGEN BLENDER
K853905 · Ohmeda Medical · Oct 1985
SECHRIST AIR-OXYGEN MIXER & ANCILLARY
K841789 · Shiley, Inc. · Jul 1984
DOWNS CAP FLOW GENERATOR
K811393 · Vital Signs, Inc. · Jun 1981