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

GKH — Predicate Candidate Screening

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

73 daysmedian FDA review time

90 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K100684	CELLTRACKS AUTOPREP SYSTEM MODEL:9541	Veridex, LLC	2010-08-26	169	0
K040077	IMMUNICON CELLTRACKS AUTOPREP SYSTEM	Immunicon Corp.	2004-03-12	58	2
K022512	CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518	Immunicon Corp.	2002-09-30	62	0
K021150	COULTER CELLPREP	Beckman Coulter, Inc.	2002-06-11	62	0
K935953	COULTER MULTI Q PREP	Coulter Corp.	1994-03-11	88	0
K923530	COULTER MULTI-Q-PREP	Coulter Electronics, Inc.	1992-10-14	90	0
K904795	FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1990-12-31	73	0
K882767	SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM	Toa Medical Electronics USA, Inc.	1988-07-18	12	0
K852373	AD150, AUTOMATED HEMATOLOGY DILUTOR	Abbott Diagnostics	1985-07-05	31	0
K842747	HYCEL DILUTOR, VARIOUS MODELS/MULTI	R&D Systems, Inc.	1984-10-01	80	0
K842446	DILU-MATIC 140	Abbott Diagnostics	1984-09-06	77	0
K823522	DILULAB 230	Innovative Medical Systems, Inc.	1982-12-28	29	0
K791644	ROYCO MODEL 371 SUPER DILUTOR	Royco Instruments	1979-09-19	27	0
K761137	MICROSAMPLE BLOOD COLLECTION DEVICE	Ortho Diagnostics, Inc.	1977-02-07	75	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