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

GJT — Predicate Candidate Screening

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

66 daysmedian FDA review time

340 days90th percentile

79clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K222831	CRYOcheck Factor VIII Deficient Plasma with VWF	Precision Biologic, Inc.	2023-09-13	359	0
K180486	HemosIL Factor XII Deficient Plasma	Instrumentation Laboratory CO	2018-03-22	27	0
K102908	NOFACT IX	R2 Diagnostics, Inc.	2011-12-19	444	0
K102851	NOFACT VIII	R2 Diagnostics, Inc.	2011-12-19	446	0
K110237	HEMOSIL FACTOR VIII DEFICIENT PLASMA	Instrumentation Laboratory CO	2011-07-08	163	0
K050661	HEMOSIL FACTOR II DEFICIENT PLASMA	Instrumentation Laboratory CO	2005-05-02	48	0
K043459	HEMOSIL FACTOR XII DEFICIENT PLASMA	Instrumentation Laboratory CO	2005-02-09	56	0
K040362	DIAPHARMA FACTOR X KIT	Diapharma Group, Inc.	2004-07-12	150	0
K034007	HEMOSIL FACTOR VIII DEFICIENT PLASMA	Instrumentation Laboratory CO	2004-02-13	51	0
K031829	HEMOSIL FACTOR IX DEFICIENT PLASMA	Instrumentation Laboratory CO	2003-07-31	48	0
K031122	HEMOSIL FACTOR X DEFICIENT PLASMA	Instrumentation Laboratory CO	2003-05-19	41	0
K030287	HEMOSIL FACTOR XI DEFICIENT PLASMA	Instrumentation Laboratory CO	2003-03-19	50	0
K024082	HEMOSIL FACTOR VII DEFICIENT PLASMA	Instrumentation Laboratory CO	2003-02-12	63	0
K023839	HEMOSIL FACTOR V DEFICIENT PLASMA	Instrumentation Laboratory CO	2003-01-14	57	0
K990814	CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02	Precision Biologic	1999-06-07	88	0
K990296	CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (	Precision Biologic	1999-03-18	49	0
K990046	PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLAS	Pacific Hemostasis	1999-02-17	41	0
K981174	CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML	Precision Biologicals, Inc.	1999-01-13	287	0
K981173	CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML	Precision Biologicals, Inc.	1999-01-13	287	0
K981709	COAGULATION FACTOR V DEFICIENT PLASMA	Dade Behring, Inc.	1998-10-13	162	0
K972627	PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA	Pacific Hemostasis	1997-08-13	30	0
K971223	CRYO CHECK FACTOR V DEFICIENT PLASMA	Precision Biologicals, Inc.	1997-07-22	111	0
K971227	CRYO CHECK FACTOR X DEFICIENT PLASMA	Precision Biologicals, Inc.	1997-07-18	107	0
K971226	CRYO CHECK FACTOR IX DEFICIENT PLASMA	Precision Biologicals, Inc.	1997-07-18	107	0
K971225	CRYO CHECK FACTOR VIII DEFICIENT PLASMA	Precision Biologicals, Inc.	1997-07-17	106	0
K971224	CRYO CHECK FACTOR VII DEFICIENT PLASMA	Precision Biologicals, Inc.	1997-07-17	106	0
K972286	FACTOR DEFICIENT PLASMAS - FACTOR XI (11)	Universal Reagents, Inc.	1997-07-14	25	0
K970607	UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA	Universal Reagents, Inc.	1997-04-25	66	0
K970593	UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA	Universal Reagents, Inc.	1997-04-25	66	0
K962675	STA - LIATEST VWF TEST KIT	American Bioproducts Co.	1996-10-25	108	1
K962671	STA-VWF CALIBRATOR KIT	American Bioproducts Co.	1996-09-13	66	0
K945857	PROTEIN C DEFICIENT PLASMA	George King Bio-Medical, Inc.	1995-10-20	340	0
K942050	HEMOLAB COFAC IX	Biomerieux Vitek, Inc.	1995-05-19	386	0
K942049	BIOMERIEUX HEMOLAB COFAC II	Biomerieux Vitek, Inc.	1995-05-19	386	0
K935850	BIOMERIEUX HEMOLAB COFAC VII	Biomerieux Vitek, Inc.	1995-01-17	405	0
K935851	BIOMERIEUX HEMOLAB COFAC X	Biomerieux Vitek, Inc.	1995-01-17	405	0
K935057	FACTOR VIII DEFICIENT PLASMA	Sigma Diagnostics, Inc.	1994-03-15	145	0
K935056	FACTOR VII DEFICIENT PLASMA	Sigma Diagnostics, Inc.	1994-03-07	137	0
K935058	FACTOR	Sigma Diagnostics, Inc.	1994-03-07	137	0
K935054	FACTOR X DEFICIENT PLASMA	Sigma Diagnostics, Inc.	1994-03-07	137	0
K934606	STAGO FACTOR II-DEFICIENT PLASMA	American Bioproducts Co.	1994-03-01	155	0
K934605	STAGO FACTOR V-DEFICIENT PLASMA	American Bioproducts Co.	1994-03-01	155	0
K933432	STAGO FACTOR IX-DEFICIENT PLASMA	American Bioproducts Co.	1993-11-15	124	0
K933444	STAGO FACTOR XI-DEFICIENT PLASMA	American Bioproducts Co.	1993-10-27	105	0
K933441	STAGO FACTOR X-DEFICIENT PLASMA	American Bioproducts Co.	1993-10-27	105	0
K933438	STAGO FACTOR XII-DEFICIENT PLASMA	American Bioproducts Co.	1993-10-27	105	0
K933440	STAGO FACTOR VII-DEFICIENT PLASMA	American Bioproducts Co.	1993-10-27	105	0
K933010	BIOMERIEUX HEMOLAB COFAC VIII	Biomerieux Vitek, Inc.	1993-09-15	86	0
K924400	CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA	Behring Diagnostics, Inc.	1993-06-08	281	0
K924396	CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA	Behring Diagnostics, Inc.	1993-05-21	263	2

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