Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tetra Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
191 daysmedian FDA review time
444 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K946277 | TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM | Tetra Corp. | 1996-03-15 | 444 | 0 |
| K945320 | TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL | Tetra Corp. | 1995-05-11 | 191 | 0 |
| K945318 | TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, | Tetra Corp. | 1995-05-05 | 185 | 0 |
| K945319 | TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT | Tetra Corp. | 1995-05-04 | 184 | 0 |
| K924204 | NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS | Tetra Corp. | 1993-06-07 | 291 | 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