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

JHN — Predicate Candidate Screening

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

227 daysmedian FDA review time

370 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K950383	APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT	Randox Laboratories, Ltd.	1995-09-15	227	0
K950382	APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT	Randox Laboratories, Ltd.	1995-09-15	227	0
K952615	WAKO AUTOKIT APO A1	Wako Chemicals USA, Inc.	1995-09-08	94	0
K952425	OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT	Olympus America, Inc.	1995-07-05	42	0
K952466	OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT	Olympus America, Inc.	1995-06-05	10	1
K932603	APOLIPOPROTIEN B (APO B)	Sigma Diagnostics, Inc.	1994-06-02	370	0
K932606	APOLIPOPROTIEN A-1 (APO A-1)	Sigma Diagnostics, Inc.	1994-06-02	370	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