Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shantou Institute of Ultrasonic Instruments Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253058 | Portable DR Imaging System | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-06-18 | 269 | 0 |
| K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2025-03-31 | 182 | 0 |
| K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15 | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2024-12-10 | 71 | 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