Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stimtech Products — 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) |
|---|---|---|---|---|---|
| K922562 | STIMTECH PFX, CATALOG NUMBER 78-8540 | Stimtech Products | 1993-10-13 | 499 | 0 |
| K903128 | STIMTRAC PC, CATALOG NO. 78-8510 | Stimtech Products | 1991-01-02 | 170 | 0 |
| K895671 | STIMTRAC II CATALOG NUMBER 78-8500 | Stimtech Products | 1989-11-06 | 47 | 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