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

LIF — Predicate Candidate Screening

57 FDA 510(k) clearances under this product code; the 50 most recent screened below.

116 daysmedian FDA review time

471 days90th percentile

57clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K091360	CLEARFLUX DIALYZER REPROCESSING SYSTEM	Novaflux Technologies	2010-11-03	544	0
K043126	ASSIST HEADER CLEANER	Alcavis International, Inc.	2005-02-03	83	0
K040660	STERICHEK GLUTARALDEHYDE REAGENT STRIPS	Hach Company	2004-11-15	248	0
K033505	RENACLEAN SH DIALYZER CLEANING SYSTEM	Minntech Corp.	2004-04-27	174	0
K024076	MAKY 21.1 DIALYZER REPROCESSING SYSTEM	Hdc Maquinolas, LLC	2003-09-26	290	0
K013713	ARM AUTOMATIC REPROCESSING MACHINE	Alcavis International Incorporated	2002-07-15	249	0
K992016	AMUKIN D	Amuchina Intl., Inc.	2000-01-10	209	0
K991851	RENACLEAR DIALYZER CLEANING SYSTEM	Minntech Corp.	1999-08-30	90	0
K974426	POTENCY TEST STRIPS, INDICATOR TEST STRIPS	Reprocessing Products Corp	1999-02-10	471	0
K974798	STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS	Environmental Test Systems, Inc.	1998-03-20	88	1
K970799	ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)	Alexander Mfg. Co.	1997-05-14	71	0
K955299	DPS 4 DIALYZER PREPARATION SYSTEM	Seratronics, Inc.	1996-10-21	336	0
K931336	DRS 4 DIALYZER REPROCESSING SYSTEM	Seratronics, Inc.	1996-04-18	1129	0
K941757	FORMALIN REUSE CART	National Medical Care, Medical Products Div., Inc.	1996-01-22	654	0
K941867	RENALIN REUSE CART	Renal Scientific Service, Inc.	1996-01-22	644	0
K944539	DRS 4 ND DIALYZER REPROCESSING SYSTEM	Seratronics, Inc.	1995-11-29	440	0
K944492	DIALYZER REPROCESSING SYSTEM	G.E.M. Water Systems	1995-08-28	349	0
K923529	DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES	Seratronics, Inc.	1994-08-29	774	0
K914123	SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS	Serim Research Corp.	1992-04-09	209	0
K914580	DRS-4 DIALYZER REPROCESSING SYSTEM	Seratronics, Inc.	1992-02-24	131	0
K911628	SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)	Serim Research Corp.	1991-06-27	77	0
K911629	SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)	Serim Research Corp.	1991-06-27	77	0
K905217	FORMASURE TEST REAGENT	Di-Chem, Inc.	1991-04-09	140	0
K902227	SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT	Serim Research Corp.	1991-04-02	320	0
K904210	RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330	Minntech Corp.	1990-11-27	76	0
K900341	SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT	Serim Research Corp.	1990-07-11	170	0
K884154	TRANSLUMINAL ENDARTERECTOMY DEVICE	Thomas J. Fogarty, M.D.	1988-12-27	85	0
K874573	FRESENIUS PURISTERIL 340 (TM)	Seratronics, Inc.	1988-04-25	172	0
K874034	ADR-22 AUTOMATIC DIALYZER REPROCESSOR	Biodynamics Corp.	1987-10-23	18	0
K870471	MODIFIED HR-3000 REUSE ADAPTOR	Colorado Medical, Inc.	1987-04-10	66	0
K870689	HR-3000 REUSE ADAPTOR	Colorado Medical, Inc.	1987-04-10	50	0
K860674	DRS-4 DIALYZER REPROCESSING SYSTEM	Seratronics, Inc.	1986-04-07	42	0
K860026	ULTRAMAX III, DIALYZER REPROCESSING DEVICE	Medicorp, Inc.	1986-03-14	70	0
K853817	COBE REN NEW-D DISPENSING KIT	Cobe Laboratories, Inc.	1985-10-17	35	0
K853413	RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS	Alcide Corp.	1985-09-06	23	0
K850799	RINSE MACHINE KR-4 KIDNEY RINSE-4	Medical Technologies International, Inc.	1985-07-29	152	0
K850127	FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G	Computer Dialysis Systems, Inc.	1985-03-20	65	0
K843520	WAREXIN RECOMMENDED ALTERNATIVE DIALYZ	Mesa Medical, Inc.	1984-10-04	27	0
K841153	ADAPTOR HR-3000 REUSE	Colorado Medical, Inc.	1984-07-16	119	0
K842258	RENATRON	Renal Systems, Inc.	1984-07-06	29	0
K833128	FORMA-FAS-TEST	Chemical Detection & Experimentation	1984-06-27	288	0
K832705	ULTRAMAX	Medicorp, Inc.	1984-06-25	318	0
K834447	ECHO MM1000	Mesa Medical, Inc.	1984-03-23	98	0
K833181	HPR HOME PATIENT RENATRON	Renal Systems, Inc.	1983-10-27	38	0
K832230	DIALYZER PREPARATION SYS DPS-4	Seratronics, Inc.	1983-10-14	95	0
K831132	COMPUDIAL/KP-1	Computer Dialysis Systems, Inc.	1983-08-08	124	0
K830722	SPORIDIDIN-D COLD STERILIZING/SOLUTION	Sporicidin Intl.	1983-06-30	114	0
K830190	AHR-3000 RE-USE ADAPTOR	Colorado Medical, Inc.	1983-05-27	128	0
K830575	RENALIN (TENTATIVE	Renal Systems, Inc.	1983-03-31	36	0
K830574	RENATRON DIALYZER REPROCESSING SYS	Renal Systems, Inc.	1983-03-29	34	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