Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Penny and Giles Biometrics , Ltd. · 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) |
|---|---|---|---|---|---|
| K962855 | ULE-2, MULE-2, HAND ACCESSORY KIT | Penny and Giles Biometrics , Ltd. | 1996-12-11 | 142 | 0 |
| K934238 | MULE | Penny and Giles Biometrics , Ltd. | 1994-10-26 | 422 | 0 |
| K924416 | BOOST, MICE, GAMESYS. | Penny and Giles Biometrics , Ltd. | 1993-06-15 | 288 | 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