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

Minntech Corp. — Predicate Candidate Screening

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

103 daysmedian FDA review time

591 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120306	RAPICIDE OPA-28	Minntech Corp.	2012-09-27	239	0
K092387	MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM	Minntech Corp.	2010-04-05	243	1
K071298	HF JUNIOR HEMOFILTER	Minntech Corp.	2007-08-08	91	0
K050952	HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR	Minntech Corp.	2006-01-31	291	0
K033505	RENACLEAN SH DIALYZER CLEANING SYSTEM	Minntech Corp.	2004-04-27	174	0
K014016	ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER	Minntech Corp.	2002-02-01	58	0
K991137	ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER	Minntech Corp.	2000-06-08	430	0
K000028	RENAFLO II HF 2000 HEMOFILTER	Minntech Corp.	2000-04-04	90	0
K991851	RENACLEAR DIALYZER CLEANING SYSTEM	Minntech Corp.	1999-08-30	90	0
K983126	FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS	Minntech Corp.	1999-03-08	181	0
K983085	HEMOCOR HPH 700 HEMOCONCENTRATOR	Minntech Corp.	1998-11-13	71	2
K980859	HEMOCOR HPH MINI HEMOCONCENTRATOR	Minntech Corp.	1998-05-12	68	0
K960513	PERACT 20 LIQUID STERILANT	Minntech Corp.	1997-10-01	604	0
K972017	BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)	Minntech Corp.	1997-09-10	103	0
K964967	BIOCOR 200 HIGH PERFORMANCEOXYGENATOR	Minntech Corp.	1997-03-06	86	0
K962707	MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET	Minntech Corp.	1996-10-09	89	0
K953821	BIOCOR 200 HARDSHELL VENOUS RESERVIOR	Minntech Corp.	1996-03-07	205	0
K954349	FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS	Minntech Corp.	1995-12-15	88	0
K941439	RENALIN COLD STERILANT	Minntech Corp.	1995-06-26	459	0
K945136	RENAGUARD DIALYSATE FILTER	Minntech Corp.	1995-02-28	131	0
K923727	PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000	Minntech Corp.	1994-07-29	732	0
K934292	WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR	Minntech Corp.	1994-07-26	327	0
K923139	HEMOCOR HP HEMOCONCENTRATOR SERIES	Minntech Corp.	1994-02-18	599	1
K923312	HIGH PERMEABILITY DIALYER	Minntech Corp.	1994-02-18	591	0
K931935	ENDPOINT 500 PERACETIC ACID TEST INDICATORS	Minntech Corp.	1994-02-07	294	0
K913483	MINNILERT(R) PRESSURE MONITOR	Minntech Corp.	1991-09-27	52	0
K910236	RENAFLO HDF 1350 HEMODIAFILTER	Minntech Corp.	1991-04-09	81	0
K904992	MINNILERT AIR DETECTOR	Minntech Corp.	1991-02-05	90	0
K904210	RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330	Minntech Corp.	1990-11-27	76	0
K894970	WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR	Minntech Corp.	1989-11-01	86	0
K882564	RENALIN COLD STERILANT	Minntech Corp.	1989-01-09	202	0
K872456	HEMOCOR PLUS HEMOCONCENTRATOR	Minntech Corp.	1987-09-15	84	0
K872107	WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR	Minntech Corp.	1987-08-28	80	0

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