Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medelec , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
141 daysmedian FDA review time
238 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965065 | TECA. MILLENNIUM | Medelec , Ltd. | 1997-06-20 | 184 | 0 |
| K964280 | DG NERVUS | Medelec , Ltd. | 1997-01-27 | 91 | 1 |
| K954157 | DG PORTABLE SYSTEM | Medelec , Ltd. | 1996-01-17 | 134 | 0 |
| K953799 | DG EXAMINER PLUS | Medelec , Ltd. | 1995-11-08 | 86 | 0 |
| K953732 | TECA PREMIERE | Medelec , Ltd. | 1995-10-19 | 80 | 0 |
| K934670 | DG 3P SYSTEM | Medelec , Ltd. | 1994-05-25 | 238 | 0 |
| K934669 | ARC | Medelec , Ltd. | 1994-04-26 | 209 | 0 |
| K923303 | SAPPHIRE PREMIERE | Medelec , Ltd. | 1992-11-24 | 141 | 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