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

NXV — Predicate Candidate Screening

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

90 daysmedian FDA review time

133 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K151630	G.o.c.c.l.e.s.	Pierrel Pharma S.R.L.	2015-09-15	90
K123169	ORALID	Forward Science, LLC	2013-03-13	155
K121282	MICROLUX/DL MICROLUX/BLU BIO/SCREEN	Addent, Inc.	2012-07-24	85
K102083	VELSCOPE VX	Led Dental, Inc.	2010-11-18	115
K101140	DENTLIGHT ORAL EXAM LIGHT KIT	Dentlight, Inc.	2010-07-15	84
K090135	TRIMIRA IDENTAFI 3000	Remicalm, LLC	2009-02-17	27
K082668	BIO-SCREEN	Addent, Inc.	2009-01-23	133
K082603	TRIMIRA OCS 3000	Remicalm, LLC	2008-12-12	95
K080043	VIZILITE EYEWEAR	Zila, Inc.	2008-04-04	87
K073483	SAPPHIRE O/E ORAL EXAMINATION SYSTEM	Den-Mat Holdings, LLC	2008-04-03	114
K070523	MODIFICATION TO: VELSCOPE	Led Dental, Inc.	2007-04-05	41
K060920	VELSCOPE	Led Medical Diagnostics, Inc.	2006-04-27	23

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