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

JCF — Predicate Candidate Screening

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

82 daysmedian FDA review time

142 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K911731	LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992-12-15	608	1
K902445	LYMPHO SEP(TM)	Icn Biomedicals, Inc.	1990-08-22	82	0
K891407	LEUCOPREP CELL SEPARATION TUBE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1989-05-26	73	1
K874328	L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA	E.I. Dupont DE Nemours & Co., Inc.	1988-02-16	117	0
K873185	DYNABEADS HLA CELL PREP II ISOLATION PRODUCT	Dynal Biotech, Inc.	1987-11-04	84	0
K872775	LEUCOPREP BRAND TUBE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-10-02	80	0
K860354	SEPRACELL LYMPHOCYTE SEPARATION MEDIUM	Sepratech Corporation C/O Keller and Heckman	1986-04-18	78	0
K854093	LEUCO PREP	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-11-12	36	0
K842818	CST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-10-23	97	0
K842146	HISTOPAQUE-1077	Sigma Chemical Co.	1984-07-27	58	0
K812947	MONO-POLY RESOLVING MEDIUM	Flow Laboratories, Inc.	1982-03-11	142	0
K812411	IMMUNO-CELL IMMUNO-SEP KIT	Kallestad Laboratories, Inc.	1981-11-10	81	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