Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Emc Industries — 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) |
|---|---|---|---|---|---|
| K952231 | EMC MODEL STATOME 200 | Emc Industries | 1995-11-21 | 193 | 0 |
| K941721 | EMC MODEL NO. 322870 ENDOSTAT | Emc Industries | 1994-07-06 | 90 | 0 |
| K911353 | EMC MODEL NO. STATOME 900 | Emc Industries | 1991-06-24 | 89 | 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