Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Oms Medical Supplies, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
222 daysmedian FDA review time
317 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963194 | ITO ACUPUNCTURE NEEDLES | Oms Medical Supplies, Inc. | 1996-08-23 | 8 | 0 |
| K920266 | TENS MODEL 240Z | Oms Medical Supplies, Inc. | 1992-12-03 | 317 | 0 |
| K904388 | POINTER F-3 TENS | Oms Medical Supplies, Inc. | 1991-06-04 | 252 | 0 |
| K904332 | MSTIM-2000 EMS | Oms Medical Supplies, Inc. | 1991-05-01 | 222 | 0 |
| K894964 | K-2 TENS OR MED TENS | Oms Medical Supplies, Inc. | 1990-01-04 | 139 | 0 |
| K884210 | TX-7 (TENS) (IC-1107) | Oms Medical Supplies, Inc. | 1988-12-12 | 67 | 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