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

KSR — Predicate Candidate Screening

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

92 daysmedian FDA review time

177 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K032827	KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501	Tyco Healthcare	2003-12-08	89	0
K020753	DEROYAL SURGICAL, UMBILICUP	Deroyal	2002-06-13	98	2
K810897	ALPHA PLASTIC PLASMA BOTTLE	Alpha Therapeutic Corp.	1981-09-23	173	0
K810500	BLOOD FREEZING BAG	Delmed, Inc.	1981-09-23	211	0
K811523	PLASMA FLEX	Terumo America, Inc.	1981-09-09	103	0
K811449	HAEMONETICS 1000ML COMPONENT BAG	Haemonetics Corp.	1981-07-01	40	0
K810711	HAEMONETICS 600 ML. COMPONENT BAG	Haemonetics Corp.	1981-05-08	52	0
K810313	HAEMONETICS 1400 ML THERAPEUTIC BAG	Haemonetics Corp.	1981-03-31	54	0
K801082	GAMBRO HEMOFREEZE-BAG	Gambro, Inc.	1980-10-31	177	0
K801219	PLASMAPOOLER	North American Biologicals, Inc.	1980-10-31	163	0
K792395	PHARMAFLEX CRYOGENIC BAG	Pharmachem Corp.	1980-02-26	92	0
K792185	PIASMA SAFE	Cry-O-Safe, Inc.	1979-12-28	58	0
K791673	EMPTY TRANSFER BAG	Delmed, Inc.	1979-10-23	56	0
K781811	TRANSFER PAK 4R 9006	Travenol Laboratories, S.A.	1978-11-08	13	0
K780354	CRYOCYTE PACK	Travenol Laboratories, S.A.	1978-06-14	103	0
K760952	TERASAKI LYMPHOCYTE TRANSPORT KIT	Dravon Medical, Inc.	1977-01-17	76	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