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

Sonotech, Inc. — Predicate Candidate Screening

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

108 daysmedian FDA review time

208 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K042619	ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTR	Sonotech, Inc.	2004-11-05	42
K033178	ULTRABIO	Sonotech, Inc.	2004-08-04	308
K031222	SCANLUBE	Sonotech, Inc.	2003-07-23	97
K031894	SCANTEC PAD	Sonotech, Inc.	2003-07-18	29
K013701	ENDO-GLIDE	Sonotech, Inc.	2002-02-04	88
K013170	SCANTAC MEMBRANE OR SCANTAC STRIP	Sonotech, Inc.	2001-11-13	50
K984562	VIVOSONIC	Sonotech, Inc.	1999-06-08	167
K983691	SCANFLEX SOLID COUPLANT MEMBRANE	Sonotech, Inc.	1999-05-05	197
K983985	HYBRISONIC SHEATH	Sonotech, Inc.	1999-02-25	108
K981028	ULTRA IMAGE AND ULTRA SCAN	Sonotech, Inc.	1998-08-21	155
K964658	OASIS	Sonotech, Inc.	1997-02-14	86
K962093	ULTRAMIX	Sonotech, Inc.	1996-12-23	208
K961692	SONOSCAN	Sonotech, Inc.	1996-08-22	113
K953468	SONOGEL	Sonotech, Inc.	1995-10-17	85

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