Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Savyon Diagnostics , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
208 daysmedian FDA review time
311 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921045 | DIASLIDE URINE CULTURING DEVICE | Savyon Diagnostics , Ltd. | 1992-09-28 | 208 | 0 |
| K914327 | SEROELISA(TM) CHLAMYDIA IGA TEST KIT | Savyon Diagnostics , Ltd. | 1992-06-09 | 256 | 0 |
| K915281 | SEROLISA CHLAMYDIA IGG TEST KIT | Savyon Diagnostics , Ltd. | 1992-03-23 | 119 | 0 |
| K910644 | IPAZYME (TM) CHLAMYDIA IGG-IGA | Savyon Diagnostics , Ltd. | 1991-03-19 | 33 | 0 |
| K901975 | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) | Savyon Diagnostics , Ltd. | 1991-03-08 | 311 | 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