Changzhou Sifary Medical Technology Co., Ltd.: FDA clearances and approvals
Changzhou Sifary Medical Technology Co., Ltd. has 5 FDA 510(k) clearances (first 2021, latest 2026), across 4 product codes in 2 review panels. Median 510(k) review time: 196 days. Since 2017 its median was 196 days, against 145 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 196 |
| 2022 | 1 | 217 |
| 2023 | 1 | 51 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 226 |
Review time against the same product codes
Since 2017, Changzhou Sifary Medical Technology Co., Ltd.'s cleared 510(k)s took a median 196 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| LQY | Locator, Root Apex | 1 | 1 |
Review panels
Most recent Changzhou Sifary Medical Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260795 | Hand-held Dental X-ray System (HyperLight-M) | EHD | 2026-09-14 | 187 |
| K252224 | Apex Locator (FindPex) | LQY | 2026-04-08 | 266 |
| K232068 | HyperLight Portable X-ray Unit | EHD | 2023-09-01 | 51 |
| K221152 | CuringPen Dental Curing Light | EBZ | 2022-11-23 | 217 |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | EKX | 2021-01-29 | 196 |
Recalls
openFDA lists no recalls under a recalling firm named Changzhou Sifary Medical Technology Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Changzhou Sifary Medical Technology Co., Ltd. have?
Changzhou Sifary Medical Technology Co., Ltd. has 5 FDA 510(k) clearances (first 2021, latest 2026), across 4 product codes in 2 review panels.
How long does FDA take to clear Changzhou Sifary Medical Technology Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Changzhou Sifary Medical Technology Co., Ltd.'s cleared 510(k)s is 196 days. Since 2017: 196 days, versus 145 days for all cleared 510(k)s in the same product codes.
What devices does Changzhou Sifary Medical Technology Co., Ltd. make?
Its most frequent FDA product codes are EHD (Unit, X-Ray, Extraoral With Timer, 2); EBZ (Activator, Ultraviolet, For Polymerization, 1); EKX (Handpiece, Direct Drive, Ac-Powered, 1).
Has Changzhou Sifary Medical Technology Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Changzhou Sifary Medical Technology Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Changzhou Sifary Medical Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EHD, Changzhou Sifary Medical Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.