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

NTN — Predicate Candidate Screening

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

83 daysmedian FDA review time

315 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K141164	ARTEMIS LIGHT ENGINE	Quest Medical Imaging	2015-03-16	315	0
K133311	ENDOLED	Olympus Winter & Ibe GmbH	2014-07-30	275	0
K130819	CLL- V1 LIGHT SOURCE	Olympus Winter & Ibe GmbH	2013-06-19	86	0
K122831	VIDEO SYSTEM CENTER	Olympus Medical Systems Corp.	2012-12-14	88	0
K113679	LUCEA LED SURGICAL LIGHT SYSTEM	Maquet S.A.S.	2012-01-12	29	1
K103813	SOPRO 281	Sopro	2011-03-22	83	0
K102167	LO-50 LED LIGHT SOURCE	Fiberoptics Technology, Inc.	2010-08-17	15	0
K091829	PLS PORTABLE LIGHT SOURCE	Optim, Inc.	2009-07-28	39	0
K090601	FSC 2	Schoelly Imaging, Inc.	2009-05-11	67	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