Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

CAK — Predicate Candidate Screening

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

52 daysmedian FDA review time

118 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K061103	HAEMONETICS 40U RBC FILTER BAG	Haemonetics Corp.	2006-05-17	27	0
K022477	SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT	Summit Medical , Ltd.	2002-10-25	88	0
K000719	NEOCARE 20 MICRON BLOOD FILTER	Whatman, Inc.	2000-05-30	88	0
K990310	CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)	Charter Medical, Ltd.	1999-08-30	210	0
K982822	FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701,	Baxter Healthcare Corp	1998-09-30	50	0
K972159	FENWAL 40 MICRON TRANSFUSION FILTER	Baxter Healthcare Corp	1997-07-23	44	0
K970225	ALPHA MICRON 20/40 MICROAGGREGATE FILTER	Alpha Therapeutic Corp.	1997-02-14	28	0
K960993	PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)	Pall Biomedical Products Co.	1996-04-22	41	1
K955515	ALPHA MICRON 20 MICROAGGREGATE FILTER	Alpha Therapeutic Corp.	1996-02-12	70	0
K904221	SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS	Baxter Healthcare Corp	1990-10-26	43	0
K904223	SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS	Baxter Healthcare Corp	1990-10-26	43	0
K901887	MODIFIED SEPACELL R-SERIES BLOOD FILTERS	Asahi Medical Co., Ltd.	1990-08-08	104	0
K896203	SOLCOSEPT(TM) BLOOD TRANSFUSION FILTER	Solco Basle, Inc.	1990-02-01	98	0
K896976	MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS	Asahi Medical Co., Ltd.	1990-01-24	42	0
K896664	MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT	Asahi Medical Co., Ltd.	1990-01-24	61	0
K890844	MICROSEPT 60/20	Arbor Technologies, Inc.	1989-06-07	106	0
K873792	SEPACELL R-500 AND SEPACELL R-500A	Advocacy International, Ltd.	1988-01-19	124	0
K873667	PALL LEUKOCYTE REMOVAL FILTER, PLATELETS	Pall Biomedical Products Co.	1988-01-06	118	0
K873666	PALL LEUKOCYTE REMOVAL FILTER, BLOOD	Pall Biomedical Products Co.	1988-01-06	118	0
K873873	RESUBMITTED MICRON TRANSFUSION FILTER	Travenol Laboratories, S.A.	1987-10-22	52	0
K864636	ERYPUR B	Organon Teknika Corp.	1987-01-14	49	0
K855064	SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE	Cobe Laboratories, Inc.	1986-03-12	84	0
K854259	SEPACELL R-500 & SEPACELL R-500A	Advocacy International, Ltd.	1986-01-08	77	0
K851370	INTERFACE TRANSFUSION BLOOD FILTER #35	Medical, Inc.	1985-06-27	83	0
K830057	20 MICRON HIGH CAPACITY TRANS/FILTER	Travenol Laboratories, S.A.	1983-01-26	19	0
K830014	HEMA - NV TRANS. BLOOD FILTER 100/800	Abbott Laboratories	1983-01-17	14	6
K823261	INTERFACE TRANSFUSION BLOOD FILTER #30	Medical, Inc.	1983-01-07	66	0
K812874	PEDIATRIC MICROAGGREGATE BLOOD FILTER	Abbott Laboratories	1981-11-02	19	0
K812697	HEMA 20 MICRON TRANSFUSION BLOOD FILTER	Abbott Laboratories	1981-10-08	16	0
K811985	ULTIPOR SQ40S BLOOD TRANSFUSION FILTER	Pall Biomedical Products Co.	1981-07-28	15	0
K810761	ALPHA MICRON-40 FILTER	Alpha Therapeutic Corp.	1981-06-30	102	0
K810855	INTERFACE 20 MICRON TRANSFUSION BLD. F.	Abbott Laboratories	1981-04-21	22	0
K780145	BLOOD FILTER, MICROEMBOLI-ATS-F10	Sorensen Research	1978-02-02	3	0
K770253	MICROFILTRATION SET MF10	Biotest-Serum-Institut	1977-04-05	55	0
K760222	FILTER, TRANSFUSION BLOOD, INTERSEPT	Surgikos, Inc.	1976-08-06	25	0
K760165	FILTER, INFUSION BLOOD (1 PFF-100)	Bentley Laboratories, Inc.	1976-08-06	31	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