Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eldeco — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
39 daysmedian FDA review time
39 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K761075 | SPORTS RECORDER (SR-10) | Eldeco | 1976-12-28 | 39 | 0 |
| K761073 | POCKET TRANSMITTER (PT-10) | Eldeco | 1976-12-28 | 39 | 0 |
| K761077 | TREND ANALYZER | Eldeco | 1976-12-28 | 39 | 0 |
| K761076 | DEMODULATOR/CARDIOTACHOMETER | Eldeco | 1976-12-28 | 39 | 0 |
| K761074 | DYNAMIC RECORDER (DR-10) | Eldeco | 1976-12-28 | 39 | 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