Atlas FDA

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

Teratech Corp. — Predicate Candidate Screening

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

17 daysmedian FDA review time
106 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K150533Terason uSmart3200T Ultrasound SystemTeratech Corp.2015-05-09680
K150148Terason uSmart3300 Ultrasound SystemTeratech Corp.2015-02-20280
K140773TERASON USMART3300 ULTRASOUND SYSTEMTeratech Corp.2014-05-30630
K140834TERASON USMART3400 ULTRASOUND SYSTEMTeratech Corp.2014-04-25230
K140524TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEMTeratech Corp.2014-03-21170
K131209TERASON USMART3200T ULTRASOUND SYSTEMTeratech Corp.2013-05-24250
K112953TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCTeratech Corp.2012-02-031220
K110482PROSOUND C3 / C3 CV ULTRASOUND SYSTEMSTeratech Corp.2011-03-18280
K110020TERASON T3200 ULTRASOUND SYSTEMTeratech Corp.2011-01-20170
K080234TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHOTeratech Corp.2008-02-14150
K051334TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLERTeratech Corp.2005-06-03110
K043278TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBESTeratech Corp.2004-12-13170
K040840TERATECH MODEL 10V5 SMART PROBETeratech Corp.2004-04-14130
K030191TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEMTeratech Corp.2003-01-2980
K012191TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER Teratech Corp.2001-07-26130
K010883TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBETeratech Corp.2001-04-06140
K992505TERATECH, MODEL 2000 IMAGING IMAGINGTeratech Corp.1999-11-101060

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