Cleared Traditional

K051192 - PRAXAIR MEDICAL AIR MIXER

K051192 is an FDA 510(k) clearance for PRAXAIR MEDICAL AIR MIXER, manufactured by Praxair, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K051192 · Praxair, Inc. · Anesthesiology device
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Sep 2005
Decision
119d
Days
Class 2
Risk

K051192 is an FDA 510(k) clearance for the PRAXAIR MEDICAL AIR MIXER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Praxair, Inc. (Tonawanda, US). The FDA issued a Cleared decision on September 6, 2005 after a review of 119 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 Praxair, Inc. devices

FDA 510(k) Submission Details - K051192

510(k) Number K051192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date September 06, 2005
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 140d · This submission: 119d
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 23
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K051192.
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K090781 · Precision Medical, Inc. · Aug 2009
PRECISION BLENDER
K053232 · Precision Medical, Inc. · Jan 2006
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K992503 · Sechrist Industries, Inc. · Aug 1999
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · Bird Products Corp. · May 1998
MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST
K925591 · Merit Medical Systems, Inc. · Sep 1993