Cleared Traditional

K945722 - MATRX MDM, RA

K945722 is an FDA 510(k) clearance for MATRX MDM, manufactured by Matrx Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K945722 · Matrx Medical, Inc. · Anesthesiology device
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Dec 1994
Decision
38d
Days
Class 2
Risk

K945722 is an FDA 510(k) clearance for the MATRX MDM, RA. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Matrx Medical, Inc. (Orchard Park, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Matrx Medical, Inc. devices

FDA 510(k) Submission Details - K945722

510(k) Number K945722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date December 29, 1994
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 140d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 154
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