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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-19 | 197 | 0 |
| K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ul | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-18 | 196 | 0 |
| K202350 | SR-1000 Portable DR Imaging System, SR-1000S Portable DR Ima | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-01-06 | 141 | 0 |
| K202353 | SR-2300 Portable DR Imaging System, SR-2300S Portable DR Ima | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-12-23 | 127 | 0 |
| K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-07-09 | 121 | 0 |
| K200976 | SR-8230, SR-8230S Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020-06-10 | 58 | 0 |
| K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2017-12-07 | 71 | 0 |
| K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler U | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2016-06-27 | 91 | 0 |
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