Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Ultrasonix Medical Corporation · Predicate Candidate Screening

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

43 daysmedian FDA review time

351 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K121812	SONIXGPS	Ultrasonix Medical Corporation	2013-12-02	530
K111818	SONIXGPS NEEDLE SENSOR	Ultrasonix Medical Corporation	2012-06-13	351
K113663	SONIXTABLET ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2012-01-25	43
K112726	SONIX ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2011-09-27	7
K102997	SONIXTABLET ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2010-12-21	75
K093462	SONIX ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2009-11-20	14
K083095	SONIXTOUCH ULTRASOUND SYSTEM	Ultrasonix Medical Corporation	2008-10-31	14
K080935	SONIX MDP ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2008-08-06	126
K061827	SONIX ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2006-08-04	37
K042326	ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2004-09-16	20
K020630	ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER	Ultrasonix Medical Corporation	2002-06-13	107

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