Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Alton (Shanghai) Medical Instruments Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
264 daysmedian FDA review time
269 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243039 | Ureteral Stents (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-06-18 | 264 | 0 |
| K242635 | Endoscopic Distal Attachment (AF-D series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-05-30 | 269 | 0 |
| K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-03-04 | 266 | 0 |
| K241285 | Disposable Endoscope Valves Set (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-10-01 | 147 | 0 |
| K231633 | Disposable Hemoclip (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-01-11 | 220 | 0 |
| K230925 | Disposable Injection Needle AF series | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023-09-27 | 177 | 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