Atlas FDA

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

Shantou Institute of Ultrasonic Instruments (Siui · Predicate Candidate Screening

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

57 daysmedian FDA review time
92 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K110841DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LIShantou Institute of Ultrasonic Instruments (Siui2011-04-15210
K103144DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LShantou Institute of Ultrasonic Instruments (Siui2011-01-12790
K102023DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEShantou Institute of Ultrasonic Instruments (Siui2010-10-19920
K101008DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAShantou Institute of Ultrasonic Instruments (Siui2010-06-08570
K061488CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEMShantou Institute of Ultrasonic Instruments (Siui2006-06-30300

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