Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Changzhou Kangdi Medical Stapler Co., Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172561 | Disposable Circular Stapler | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-12-05 | 102 | 0 |
| K172538 | Disposable Linear Stapler, Disposable Linear Cutter | Changzhou Kangdi Medical Stapler Co., Ltd. | 2017-11-30 | 100 | 0 |
| K121474 | DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER | Changzhou Kangdi Medical Stapler Co., Ltd. | 2012-07-16 | 59 | 0 |
| K100723 | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MOD | Changzhou Kangdi Medical Stapler Co., Ltd. | 2010-04-30 | 46 | 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