Smedtrum Medical Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Smedtrum Medical Technology Co., Ltd.” (first 2022, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Since 2017 the median was 87 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 105 |
| 2023 | 2 | 86 |
| 2024 | 2 | 96 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Smedtrum Medical Technology Co., Ltd. took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 3 | 3 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 2 | 2 |
Review panels
Most recent Smedtrum Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240482 | Intense Pulsed Light System (ST-690) | ONF | 2024-05-17 | 87 |
| K240118 | Picosecond Nd:YAG Laser System | GEX | 2024-04-30 | 105 |
| K231394 | Intense Pulsed Light System | ONF | 2023-08-09 | 86 |
| K230580 | Diode Laser System | GEX | 2023-05-26 | 85 |
| K221597 | CO2 Laser System | GEX | 2022-09-15 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Smedtrum Medical Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Smedtrum Medical Technology Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Smedtrum Medical Technology Co., Ltd.” (first 2022, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Smedtrum Medical Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smedtrum Medical Technology Co., Ltd. is 87 days. Since 2017: 87 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Smedtrum Medical Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 3); ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 2).
Next steps
- See all 5 Smedtrum Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Smedtrum Medical Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.