Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oms Medico, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
83 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874550 | TX-4(TENS) (SIGMA TENS) | Oms Medico, Inc. | 1987-11-20 | 16 | 0 |
| K874333 | TX-2(TENS) | Oms Medico, Inc. | 1987-11-20 | 29 | 0 |
| K873420 | GLOBALCARE(TENS) | Oms Medico, Inc. | 1987-10-08 | 43 | 0 |
| K873484 | 120Z(TENS) | Oms Medico, Inc. | 1987-09-16 | 16 | 0 |
| K871699 | TX-3(TENS) | Oms Medico, Inc. | 1987-06-25 | 55 | 0 |
| K870583 | NEU-PULS(TENS) MODEL #295 | Oms Medico, Inc. | 1987-03-17 | 34 | 0 |
| K865063 | UNI-PULS(TENS) MODEL #292 | Oms Medico, Inc. | 1987-03-17 | 83 | 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