Cleared Traditional

K974372 - AIR OXYGE MIXER

K974372 is an FDA 510(k) clearance for AIR OXYGE 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 77-day FDA review.

K974372 · Sk Med · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
77d
Days
Class 2
Risk

K974372 is an FDA 510(k) clearance for the AIR OXYGE 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 February 5, 1998 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sk Med devices

FDA 510(k) Submission Details - K974372

510(k) Number K974372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1997
Decision Date February 05, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 35
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K974372.
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
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · Bird Products Corp. · May 1998
ALADDIN MONITORING OXYGEN/AIR MIXER
K960359 · Hamilton Medical, Inc. · Apr 1996
AIR ENTRAINER 900RT008
K953711 · Fisher & Paykel Electronics , Ltd. · Nov 1995
OXY/STAR LOW FLOW BLENDER
K952878 · Infrasonics Corp. · Sep 1995