Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med Telectronics , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
10 daysmedian FDA review time
19 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K770661 | GENERATOR, PULSE, IMPLANTABLE | Med Telectronics , Ltd. | 1977-04-26 | 19 | 0 |
| K770282 | WEDGE TIP, SMALL, MODEL #030-191 | Med Telectronics , Ltd. | 1977-02-24 | 10 | 0 |
| K770283 | WEDGE TIP, SMALL, MODEL #030-194 | Med Telectronics , Ltd. | 1977-02-24 | 10 | 0 |
| K770285 | BALL TIP, MODEL #030-188 | Med Telectronics , Ltd. | 1977-02-24 | 10 | 0 |
| K770284 | BALL TIP, MODEL #030-185 | Med Telectronics , Ltd. | 1977-02-24 | 10 | 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