Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Syntex Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
85 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920314 | TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) | Syntex Corp. | 1992-04-17 | 85 | 0 |
| K843593 | SURGIPRESS SURGICAL LOOP | Syntex Corp. | 1984-10-24 | 42 | 0 |
| K780997 | AMALGAM ALLOY | Syntex Corp. | 1978-07-27 | 43 | 0 |
| K780769 | S-100 CT SCANNER | Syntex Corp. | 1978-06-02 | 28 | 0 |
| K780483 | FIBER OPTIC HANDPIECE | Syntex Corp. | 1978-04-28 | 32 | 0 |
| K761331 | OPUS I OPTION - FIBER OPTIC L SYSTEM | Syntex Corp. | 1977-01-03 | 7 | 0 |
| K761330 | SYNTEX SYSTEM 6000 | Syntex Corp. | 1976-12-30 | 3 | 0 |
| K761332 | HI-SENSITIVITY MODE OPTION FOR S60-1A | Syntex Corp. | 1976-12-30 | 3 | 0 |
| K761264 | OPTIONS FOR STAR DENTAL OPUS I | Syntex Corp. | 1976-12-23 | 7 | 0 |
| K761033 | COMPUTERIZED TOMOGRAPHY SCANNER | Syntex Corp. | 1976-11-24 | 9 | 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