Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Derata Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
246 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883847 | DERATA MEDI-JECTOR V | Derata Corp. | 1988-10-31 | 49 | 0 |
| K864561 | DERATA MEDI-JECTOR IV | Derata Corp. | 1987-02-19 | 92 | 0 |
| K844244 | DERATA MEDI-JECTOR PRO | Derata Corp. | 1985-07-05 | 246 | 0 |
| K844111 | DERATA MEDI-JECTOR III | Derata Corp. | 1984-11-28 | 36 | 0 |
| K834044 | MEDI-JECTOR II | Derata Corp. | 1984-03-06 | 104 | 0 |
| K772129 | MEDI-JECTOR | Derata Corp. | 1977-12-08 | 27 | 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