Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smedtrum Medical Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
105 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240482 | Intense Pulsed Light System (ST-690) | Smedtrum Medical Technology Co., Ltd. | 2024-05-17 | 87 | 0 |
| K240118 | Picosecond Nd:YAG Laser System | Smedtrum Medical Technology Co., Ltd. | 2024-04-30 | 105 | 0 |
| K231394 | Intense Pulsed Light System | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 | 86 | 0 |
| K230580 | Diode Laser System | Smedtrum Medical Technology Co., Ltd. | 2023-05-26 | 85 | 0 |
| K221597 | CO2 Laser System | Smedtrum Medical Technology Co., Ltd. | 2022-09-15 | 105 | 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