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

LNJ — Predicate Candidate Screening

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

88 daysmedian FDA review time

179 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K050236	FISHVIEW	Applied Spectral Imaging , Ltd.	2005-06-27	147
K012103	BANDVIEW SYSTEM	Applied Spectral Imaging , Ltd.	2001-09-14	71
K940240	IKAROS	Metasystems GmbH	1995-02-24	401
K912085	ACLAIMS-IS	W-Technology	1991-10-31	171
K902311	GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO.	Applied Imaging Corp.	1990-08-20	89
K895095	AKS II	Amoco Technology Co.	1990-02-09	179
K872755	KARYOTEC 100	Amcor Electronics, Ltd.	1987-09-01	50
K864955	CYTOSCAN	Image Recognition Systems , Ltd.	1987-03-16	88
K861974	PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST	Perceptive Systems, Inc.	1986-08-04	75
K851508	NIKON/JOYCE LOCK MAGICAN 2 CHROMOSOME SYS	Nikon, Inc.	1985-07-12	88
K851174	METACHROME	Potomac Medical System	1985-05-23	59

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