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

Natus Medical Incorporated · Predicate Candidate Screening

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

139 daysmedian FDA review time

269 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K182178	neoBLUE blanket LED Phototherapy System	Natus Medical Incorporated	2018-12-13	122	0
K182263	RetCam 3 ; RetCam Shuttle ; RetCam Portable	Natus Medical Incorporated	2018-09-07	17	0
K160745	neoBLUE compact LED Phototherapy System	Natus Medical Incorporated	2016-12-12	269	0
K160305	neoBLUE® LED Phototherapy System	Natus Medical Incorporated	2016-05-27	113	0
K143440	Natus Quantum	Natus Medical Incorporated	2015-04-20	139	0
K141446	ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, E	Natus Medical Incorporated	2014-08-22	81	0
K112247	A BAER WITH ABAER I/O FUNCTION	Natus Medical Incorporated	2012-04-02	242	0
K111618	AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O	Natus Medical Incorporated	2011-12-28	201	0
K103589	NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM	Natus Medical Incorporated	2011-05-13	157	2
K100683	NEUROLINK IP MODEL: PK1117	Natus Medical Incorporated	2010-04-09	30	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