Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dk Medical Systems 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) |
|---|---|---|---|---|---|
| K253446 | AeroDR TX c02 | Dk Medical Systems Co., Ltd. | 2026-04-10 | 190 | 0 |
| K250790 | INNOVISION-DXII | Dk Medical Systems Co., Ltd. | 2025-08-01 | 140 | 0 |
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | 2025-07-18 | 128 | 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