Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medimatic — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
374 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862511 | TOMOMATIC 232 | Medimatic | 1987-07-10 | 374 | 0 |
| K851128 | DIGITMATIC DM2 | Medimatic | 1985-07-19 | 121 | 0 |
| K810006 | TOMOMATIC 64 | Medimatic | 1981-02-02 | 28 | 0 |
| K781742 | INHAMATIC 33 | Medimatic | 1978-12-04 | 48 | 0 |
| K781352 | STRAIN GAUGE PLETHYSMOGRAPH | Medimatic | 1978-10-27 | 81 | 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