510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K945722Substantially Equivalent

Matrx Mdm, Ra

Matrx Medical, Inc., Orchard Park NY / Traditional, Substantially Equivalent

K945722 is the FDA 510(k) clearance record for MATRX MDM, RA, a class II device, cleared for Matrx Medical, Inc. on under FDA product code BSZ (Gas-Machine, Anesthesia). FDA records list one 510(k) clearance for Matrx Medical, Inc. As of , FDA records show no recalls naming K945722.

Clearance record

Decision date
Received
(38 days to decision)
Product code
BSZ Gas-Machine, Anesthesia
Regulation
21 CFR 868.5160
Device class
Class II
Review panel
Anesthesiology
Applicant
Matrx Medical, Inc. 145 Mid County Dr., Orchard Park NY
510(k) summary
Statement
Third party review
No

Clearances, product code BSZ

Trailing 12 months
2 clearances under product code BSZ in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260