Cleared Traditional

K883833 - NITRONOX(R), FIRST RESPONSE NITRONOX(TM)

K883833 is an FDA 510(k) clearance for NITRONOX, manufactured by Matrix Medica, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K883833 · Matrix Medica, Inc. · Anesthesiology device
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Feb 1989
Decision
161d
Days
Class 2
Risk

K883833 is an FDA 510(k) clearance for the NITRONOX(R), FIRST RESPONSE NITRONOX(TM). Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 161 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.

View all Matrix Medica, Inc. devices

FDA 510(k) Submission Details - K883833

510(k) Number K883833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1988
Decision Date February 17, 1989
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 140d · This submission: 161d
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 32
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K883833.
BIRD SENTRY AIR/OXYGEN MICROBLENDER
K911962 · Bird Products Corp. · Oct 1991
LOW FLOW N2O/02O MICROBLENDER
K900722 · Bird Products Corp. · Jul 1990
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
THE M100 AIR/OXYGEN MIXER
K860373 · Newport Medical Instruments, Inc. · May 1986