Alton (Shanghai) Medical Instruments Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Alton (Shanghai) Medical Instruments Co., Ltd.” (first 2023, latest 2025), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 242 days. Since 2017 the median was 242 days, against 167 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 |
|---|---|---|
| 2023 | 1 | 177 |
| 2024 | 2 | 184 |
| 2025 | 3 | 266 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alton (Shanghai) Medical Instruments Co., Ltd. took a median 242 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 167 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAD | Stent, Ureteral | 1 | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 1 | 1 |
| KTI | Bronchoscope Accessory | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Alton (Shanghai) Medical Instruments Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243039 | Ureteral Stents (AF-D series) | FAD | 2025-06-18 | 264 |
| K242635 | Endoscopic Distal Attachment (AF-D series) | FDS | 2025-05-30 | 269 |
| K241679 | Disposable Cytology Brush (AF series) | KTI | 2025-03-04 | 266 |
| K241285 | Disposable Endoscope Valves Set (AF series) | ODC | 2024-10-01 | 147 |
| K231633 | Disposable Hemoclip (AF series) | PKL | 2024-01-11 | 220 |
| K230925 | Disposable Injection Needle AF series | FBK | 2023-09-27 | 177 |
Recalls
openFDA lists no recalls under a recalling firm named Alton (Shanghai) Medical Instruments 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Alton Dean Medical, Inc. (1 510(k)s)
- Alton Design, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alton (Shanghai) Medical Instruments Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Alton (Shanghai) Medical Instruments Co., Ltd.” (first 2023, latest 2025), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alton (Shanghai) Medical Instruments Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alton (Shanghai) Medical Instruments Co., Ltd. is 242 days. Since 2017: 242 days, versus 167 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alton (Shanghai) Medical Instruments Co., Ltd.?
The most frequent FDA product codes under this applicant name are FAD (Stent, Ureteral, 1); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FDS (Gastroscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 6 Alton (Shanghai) Medical Instruments Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FAD, Alton (Shanghai) Medical Instruments 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.