Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tetrad Corp. — 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) |
|---|---|---|---|---|---|
| K042620 | SONATA 3-D IMAGING ACCESSORY, MODEL 3DS | Tetrad Corp. | 2004-12-23 | 87 | 0 |
| K014182 | TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANS | Tetrad Corp. | 2002-01-03 | 14 | 1 |
| K013849 | TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS | Tetrad Corp. | 2001-12-03 | 13 | 0 |
| K002193 | TETRAD TC-C3-ACP | Tetrad Corp. | 2001-05-04 | 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