Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Truphatek, 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) |
|---|---|---|---|---|---|
| K923227 | THROAT-A-SCOPE | Truphatek, Ltd. | 1992-12-04 | 156 | 0 |
| K920272 | ORIEL | Truphatek, Ltd. | 1992-07-09 | 169 | 0 |
| K902205 | OTOSCOPE | Truphatek, Ltd. | 1990-08-14 | 90 | 0 |
| K883414 | LARYNGOSCOPE BLADES | Truphatek, Ltd. | 1988-08-19 | 4 | 1 |
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