Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Koios Medical, Inc. — 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) |
|---|---|---|---|---|---|
| K253884 | Koios DS (3.8) | Koios Medical, Inc. | 2026-07-02 | 210 | 0 |
| K242130 | Koios DS | Koios Medical, Inc. | 2024-11-15 | 116 | 0 |
| K212616 | Koios DS | Koios Medical, Inc. | 2021-12-16 | 120 | 0 |
| K190442 | Koios DS for Breast | Koios Medical, Inc. | 2019-07-03 | 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