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

Nico Corporation — Predicate Candidate Screening

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

88 daysmedian FDA review time

225 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K232567	Myriad SPECTRA Light Source	Nico Corporation	2024-03-14	203	1
K191599	NICO Myriad NOVUS	Nico Corporation	2019-09-13	88	3
K182340	NICO Myriad	Nico Corporation	2018-09-20	23	0
K172433	NICO BrainPath	Nico Corporation	2017-09-07	27	0
K161307	NICO Myriad	Nico Corporation	2016-12-21	225	0
K162075	NICO TRIOwand	Nico Corporation	2016-08-11	15	0
K150378	NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd'	Nico Corporation	2015-06-12	119	0
K150993	NICO TRIOwand	Nico Corporation	2015-04-23	8	0
K120691	BRAIN PORT	Nico Corporation	2012-06-05	90	2

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