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

Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · Predicate Candidate Screening

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

127 daysmedian FDA review time
197 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000ExpShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2021-08-191970
K210318Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler UlShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2021-08-181960
K202350SR-1000 Portable DR Imaging System, SR-1000S Portable DR ImaShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2021-01-061410
K202353SR-2300 Portable DR Imaging System, SR-2300S Portable DR ImaShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2020-12-231270
K200637SR-8100 Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2020-07-091210
K200976SR-8230, SR-8230S Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2020-06-10580
K173000Apogee 2100 Digital Color Doppler Ultrasound Imaging System Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2017-12-07710
K160853Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler UShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)2016-06-27910

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