Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stat Medical Devices — 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) |
|---|---|---|---|---|---|
| K230310 | STAT Medical Device Lancing System | Stat Medical Devices | 2023-09-08 | 217 | 0 |
| K222617 | EasyTouch Lancing Device | Stat Medical Devices | 2023-03-21 | 203 | 0 |
| K223815 | ONE DROP Lancing Device | Stat Medical Devices | 2023-02-15 | 57 | 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