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

Nicolet Biomedical — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

104 daysmedian FDA review time

410 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K020754	NICOLET PIONEER TC8080	Nicolet Biomedical	2003-04-21	410	0
K013281	VERSALAB APM	Nicolet Biomedical	2002-04-18	198	0
K013419	NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM	Nicolet Biomedical	2001-12-20	66	0
K011135	GSI AUDERA	Nicolet Biomedical	2001-07-26	104	1
K010521	NICOLET VERSALAB	Nicolet Biomedical	2001-03-09	15	0
K002766	NICOLET VASOGUARD	Nicolet Biomedical	2000-11-30	86	0
K993939	NICOLET EME LEGEND TC22	Nicolet Biomedical	2000-06-29	223	0
K982635	CAREDOP II	Nicolet Biomedical	1998-08-07	25	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