Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Verimed Holdings, Inc. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
226 daysmedian FDA review time
297 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981277 | PERIFORM | Verimed Holdings, Inc. | 1998-11-20 | 226 | 0 |
| K954127 | BIOFEEDBACK DEVICE | Verimed Holdings, Inc. | 1995-11-14 | 75 | 0 |
| K951969 | MYOEXORCISER II FUAL | Verimed Holdings, Inc. | 1995-06-14 | 48 | 0 |
| K930670 | PHYACTION 787 | Verimed Holdings, Inc. | 1993-07-02 | 143 | 0 |
| K922550 | ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) | Verimed Holdings, Inc. | 1992-12-10 | 195 | 0 |
| K913912 | VERIMED PERINEOMETER | Verimed Holdings, Inc. | 1992-06-16 | 292 | 0 |
| K893220 | VERIMED MYOEXORCISER VERISTIM | Verimed Holdings, Inc. | 1990-03-07 | 314 | 0 |
| K892649 | VERIMED MYOEXORCISER III (MYO III) | Verimed Holdings, Inc. | 1989-12-13 | 245 | 0 |
| K874212 | VERIMED MYO/PREMS | Verimed Holdings, Inc. | 1988-08-08 | 297 | 0 |
| K854193 | ELECTRO-MYOGRAPHIC PERINEOMETER | Verimed Holdings, Inc. | 1986-06-09 | 237 | 0 |
| K852963 | MYO-ACTUATOR | Verimed Holdings, Inc. | 1986-01-21 | 193 | 0 |
| K832714 | VERIMED MYOEXORCISER | Verimed Holdings, Inc. | 1983-10-28 | 77 | 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