Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kossel Medtech (Suzhou) Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
219 daysmedian FDA review time
249 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231402 | HP PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2023-12-20 | 219 | 0 |
| K221245 | PTA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-12-14 | 226 | 0 |
| K211349 | Selebrek PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2022-01-07 | 249 | 0 |
| K211393 | Selethru(TM) NC PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2021-07-02 | 58 | 0 |
| K182699 | Selethru PTCA Balloon Dilatation Catheter | Kossel Medtech (Suzhou) Co., Ltd. | 2018-11-26 | 60 | 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