Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Counter Scientific Development (Gz), Ltd. — 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) |
|---|---|---|---|---|---|
| K161537 | OTC TENS Device, Model PTS-IV | Counter Scientific Development (Gz), Ltd. | 2016-10-13 | 132 | 0 |
| K150277 | Pain Therapy System, Model PTS-II | Counter Scientific Development (Gz), Ltd. | 2016-02-12 | 372 | 0 |
| K151279 | Counter OTC TENS Device, Model CSD-737Z | Counter Scientific Development (Gz), Ltd. | 2015-12-16 | 216 | 0 |
| K132993 | COUNTER OTC TENS DEVICE | Counter Scientific Development (Gz), Ltd. | 2014-04-24 | 212 | 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