Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Talia Technology , Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
358 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2006-08-23 | 70 | 0 |
| K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2004-05-24 | 11 | 0 |
| K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2003-05-06 | 12 | 0 |
| K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2000-03-31 | 25 | 0 |
| K964137 | RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 1997-02-03 | 111 | 0 |
| K930518 | TALIA LASER SLIT | Talia Technology , Ltd. | 1994-01-25 | 358 | 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