Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Milestone Scientific, 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) |
|---|---|---|---|---|---|
| K221702 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2023-02-25 | 257 | 0 |
| K161883 | CompuFlo Epidural Computer Controlled Anesthesia System | Milestone Scientific, Inc. | 2017-06-09 | 333 | 0 |
| K061904 | COMPUDENT STA | Milestone Scientific, Inc. | 2006-08-08 | 34 | 1 |
| K053554 | COMPUFLO | Milestone Scientific, Inc. | 2006-07-10 | 202 | 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