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

FPB — Predicate Candidate Screening

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

70 daysmedian FDA review time

182 days90th percentile

98clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K233277	Filter Needle for Single Use	Hangzhou Qiantang Longyue Biotechnology Co., Ltd.	2024-05-10	224	0
K143583	Cathivex ¿GV filter units	Merck Millipore , Ltd.	2015-08-11	236	0
K113227	NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER	Baxter Healthcare Corp	2011-12-08	37	0
K021293	ARTERIA BLOOD FILTER	Arteria Medical Science, Inc.	2002-08-22	121	0
K993379	PALL SUPOR AEF FILTER	Pall Corp.	1999-12-16	70	0
K974661	0.2 U BACTERIAL FILTER	Sims Deltec, Inc.	1998-02-11	58	0
K964283	AUTOPRIME	Arbor Technologies, Inc.	1997-01-22	86	0
K954331	PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)	Pall Biomedical Products Co.	1997-01-09	482	0
K933523	I.V. FILTER SET	Mediziv Medical Products 1987 , Ltd.	1995-05-19	668	0
K941628	40 MICRON BLOOD TRANSFUSION FILTER	Douglas Medical Products Corp.	1995-02-16	318	0
K942625	1.2 MICRON AIR ELIMINATING FILTER	The Medi-Dose Group	1994-10-07	127	0
K943127	PHARMASSURE LARGE VOLUME TRANSFER FILTERS	Gelman Sciences, Inc.	1994-09-29	92	0
K942532	2 MICRON AIR ELIMINATING FILTER	Medi-Dose, Inc.	1994-08-17	82	0
K941684	IVEX-2 EXTENSION SET WITH Y-INJECTION SITE	Abbott Laboratories	1994-08-03	121	0
K942275	VIAL VENT FILTER	Gelman Sciences, Inc.	1994-07-26	77	0
K940980	CHARGED SUPOR(R) FILTER EXTENSION SET	B. Braun of America, Inc.	1994-07-14	135	0
K933869	EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER	Baxter Healthcare Corp	1994-04-26	260	0
K940293	1.2 MICRON FINAL FILTER WITH EXTENSION TUBE	Puritas Health Care, Inc.	1994-03-28	66	0
K933294	MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES	Aesculap, Inc.	1994-02-09	217	0
K935641	0.2. MICRON FILTER SETS AND 1.2 MICRON FILTER SETS	Evans Medical, Inc.	1994-01-28	67	0
K932301	FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER	Baxter Healthcare Corp	1993-11-10	182	2
K931441	FENWAL 40 MICRON TRANSFUSION FILTER	Baxter Healthcare Corp	1993-09-21	183	0
K920736	IVEX-HP96 EXTENDED LIFE FILTER SET	Abbott Laboratories	1993-04-23	429	9
K913308	IVEX-TPN EXTENSION FILTER SET	Abbott Laboratories	1992-01-15	174	1
K912848	I.V. FILTER EXTENSION SET	Filtertek, Inc.	1991-11-29	154	0
K905794	PALL 3N1 FILTER	Pall Biomedical Products Co.	1991-06-13	168	1
K911451	I.V. EXTENDER SET	Filtertek, Inc.	1991-06-06	64	0
K896333	CMS IV FILTERS	Churchill Medical Systems, Inc.	1990-01-11	69	0
K896292	1.2 MICRON FILTER WITH IV SET	Kendall Mcgaw Laboratories, Inc.	1989-12-08	38	0
K894954	.22 & 1.2 MICRON IV FILTERS	Churchill Medical Systems, Inc.	1989-11-13	101	0
K880605	LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER	Miles Laboratories, Inc.	1988-05-26	104	0
K880025	CHURCHILL 0.22 MICRON LIQUID FILTER SETS	Churchill Corp.	1988-04-14	100	0
K880026	CHURCHILL 0.22 MICRON LIQUID COMPACT FILTER SETS	Churchill Corp.	1988-04-14	100	0
K880027	CHURCHILL 1.2 MICRON LIQUID FILTER SET	Churchill Corp.	1988-04-13	99	0
K872634	CUTTER PUREFLO PLUS IV FILTER	Miles Laboratories, Inc.	1987-08-04	29	0
K865029	CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER	Travenol Laboratories, S.A.	1987-04-17	115	0
K864113	CLYDE (TM) FILTRATION SYSTEM	Arbor Technologies, Inc.	1987-02-04	106	0
K861644	CRITIKON 48-HOUR AIR ELIMINATING FILTER	Critikon Company, LLC	1986-07-22	83	0
K860372	FAST FLOW XX (AQUEOUS SOLUTION FILTER)	Healthtek, Inc.	1986-05-30	116	0
K860803	IV FILTER EXTENSION SET	Med Fusion Systems, Inc.	1986-04-09	36	0
K860746	AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER	Travenol Laboratories, S.A.	1986-04-07	39	2
K855065	PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE	Cobe Laboratories, Inc.	1986-02-28	72	0
K854172	I.V. WATCH	Alltek, Inc.	1985-12-05	51	0
K852996	DYNA GARD SYRINGE FILTER	Microgon, Inc.	1985-09-19	66	0
K851818	SARTORIUS MINI SART FH 16592	Sartorius Filters, Inc.	1985-08-19	115	0
K851817	SARTORIUS MINI-SART FH 16555	Sartorius Filters, Inc.	1985-08-19	115	0
K851816	SARTORIUS MINISART FH 16534	Sartorius Filters, Inc.	1985-08-19	115	0
K852030	PEDIATRIC IV WATCH	Alltek, Inc.	1985-05-30	22	0
K852029	I.V. WATCH	Alltek, Inc.	1985-05-30	22	0
K850825	AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR	Pall Biomedical Products Co.	1985-04-09	40	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