Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Matrix Medica, Inc. — Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

102 daysmedian FDA review time

913 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K961536	FLEXSCOPE	Matrix Medica, Inc.	1996-09-18	149
K923693	KLORMAN	Matrix Medica, Inc.	1996-01-23	1279
K921982	MATRX HOPE(R) 5 RESUSCITATOR	Matrix Medica, Inc.	1994-10-28	913
K915353	MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP	Matrix Medica, Inc.	1991-12-27	31
K912661	MATRX, PYRAMID TRIANGLE BANDAGE	Matrix Medica, Inc.	1991-08-21	64
K900551	MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.	Matrix Medica, Inc.	1990-05-09	92
K895533	LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER	Matrix Medica, Inc.	1990-01-26	135
K895525	MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER	Matrix Medica, Inc.	1990-01-26	136
K893219	MATRX DENTAL UNIT	Matrix Medica, Inc.	1989-08-07	102
K883833	NITRONOX(R), FIRST RESPONSE NITRONOX(TM)	Matrix Medica, Inc.	1989-02-17	161
K884879	CENTURION(TM) MIXER	Matrix Medica, Inc.	1989-02-09	80
K873277	MITRAFLEX(TM) WOUND DRESSING	Matrix Medica, Inc.	1987-09-17	31
K850661	MATRIX DRI-IDEA BOOTIES	Matrix Medica, Inc.	1985-03-11	19
K850177	MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN)	Matrix Medica, Inc.	1985-02-21	35

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda