Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Epm Information Systems, 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) |
|---|---|---|---|---|---|
| K935518 | MOVING IMAGES(TM) | Epm Information Systems, Inc. | 1994-05-17 | 195 | 0 |
| K923033 | THE TRACKER | Epm Information Systems, Inc. | 1993-06-01 | 435 | 0 |
| K922112 | EASYFLOW | Epm Information Systems, Inc. | 1992-12-07 | 216 | 0 |
| K903300 | RESP-EZ(TM) RESPIRATORY MONITORING BELT | Epm Information Systems, Inc. | 1990-12-28 | 157 | 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