Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Changzhou Waston Medical Appliance Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
241 daysmedian FDA review time
638 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K211197 | Disposable Endoscopic Cutter Stapler and Cartridge | Changzhou Waston Medical Appliance Co., Ltd. | 2023-01-19 | 638 | 0 |
| K151062 | WASTON Metallic Intramedullary Nail System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-12-17 | 241 | 0 |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 | 246 | 0 |
| K151057 | WASTON Metallic Bone Plate and Screw Systems | Changzhou Waston Medical Appliance Co., Ltd. | 2015-08-10 | 112 | 0 |
| K100386 | DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 | Changzhou Waston Medical Appliance Co., Ltd. | 2010-03-01 | 13 | 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