Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micropace Pty, 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) |
|---|---|---|---|---|---|
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO) | Micropace Pty, Ltd. | 2026-06-12 | 262 | 0 |
| K072200 | STIMLAB | Micropace Pty, Ltd. | 2007-10-26 | 79 | 0 |
| K011826 | EPS320 CARDIAC STIMULATOR | Micropace Pty, Ltd. | 2002-01-24 | 227 | 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