Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dk Medical Technology Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242254 | D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2025-04-21 | 264 | 0 |
| K232207 | D·Kutting™ PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2024-03-07 | 225 | 0 |
| K214009 | D·Kaptain PTA High Pressure Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | 2023-04-05 | 516 | 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