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

Pacific Hemostasis — Predicate Candidate Screening

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

42 daysmedian FDA review time

97 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K000679	THROMBOSTRATE CONTROL PLASMAS	Pacific Hemostasis	2000-03-24	24	0
K994100	PACIFIC HEMOSTASIS THROMBOPLASTIN D	Pacific Hemostasis	2000-02-18	77	2
K992130	PACIFIC HEMOSTASIS THROMBOSCREEN 400C	Pacific Hemostasis	1999-09-03	72	0
K992279	HEPARIN CONTROL PLASMA LEVEL 2	Pacific Hemostasis	1999-08-26	50	0
K992278	HEPARIN CONTROL PLASMA LEVEL 1	Pacific Hemostasis	1999-08-26	50	0
K991321	PACIFIC HEMOSTASIS THROMBOSCREEN 200	Pacific Hemostasis	1999-06-21	63	0
K990046	PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLAS	Pacific Hemostasis	1999-02-17	41	0
K984130	COAGULATION CONTROL LEVEL 2 (ABNORMAL)	Pacific Hemostasis	1998-12-01	13	0
K984131	COAGULATION CONTROL LEVEL 3 (ABNORMAL)	Pacific Hemostasis	1998-12-01	13	0
K984129	COAGULATION CONTROL LEVEL 1 (NORMAL)	Pacific Hemostasis	1998-12-01	13	0
K972627	PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA	Pacific Hemostasis	1997-08-13	30	0
K971428	COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0	Pacific Hemostasis	1997-06-17	61	0
K940082	THROMBOSCREEN THROMBOPLASTIN-DS	Pacific Hemostasis	1995-02-14	403	0
K891337	THROMBOSCREEN APTT REAGENT	Pacific Hemostasis	1989-04-21	42	0
K872217	THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT	Pacific Hemostasis	1987-07-31	52	0
K864643	GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT	Pacific Hemostasis	1987-04-28	153	0
K854079	THROMBO SCREEN SICKLE CELL ASSAY SET	Pacific Hemostasis	1985-10-31	24	1
K852512	THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT	Pacific Hemostasis	1985-09-17	97	0
K834086	CONTACT-K APTT REAGENT	Pacific Hemostasis	1984-02-03	67	0
K820450	THROMBOSCREEN	Pacific Hemostasis	1982-03-26	36	0
K812658	CEA CONTROL PLASMA	Pacific Hemostasis	1981-09-29	11	0
K812215	ANTITHROMBIN III SCREEN KIT	Pacific Hemostasis	1981-09-01	27	0
K810350	THROMBOPLASTIN	Pacific Hemostasis	1981-04-14	63	0
K801460	PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT	Pacific Hemostasis	1980-07-28	34	0
K800826	FIBRINOGEN SCREEN	Pacific Hemostasis	1980-05-30	46	0
K800146	PLATELET AGGREGATION REAGENTS	Pacific Hemostasis	1980-02-05	14	0
K791022	PROTHROMBIN REFERENCE PLASMA (HUMAN)	Pacific Hemostasis	1979-07-24	55	0
K791023	PROTHROMBIN FREE BEEF PLASMA (PFB)	Pacific Hemostasis	1979-06-28	29	0
K781880	ASSAY KIT, THROMBO-SCREEN	Pacific Hemostasis	1978-12-04	28	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