Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Engineering and Development Institute · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
252 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K902477 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET | Medical Engineering and Development Institute | 1990-08-24 | 81 | 0 |
| K902469 | BYRD DILATOR SHEATH SET - TEFLON | Medical Engineering and Development Institute | 1990-08-23 | 80 | 0 |
| K902502 | BYRD STAINLESS STEEL DILATOR | Medical Engineering and Development Institute | 1990-08-07 | 63 | 0 |
| K895030 | LIFE-LINE(TM) VASCULAR ACCESS SYSTEM | Medical Engineering and Development Institute | 1990-04-17 | 252 | 0 |
| K893480 | BYRD EXTRACTOR SET | Medical Engineering and Development Institute | 1989-06-23 | 50 | 0 |
| K890820 | LOCKING WIRE GUIDE STYLET | Medical Engineering and Development Institute | 1989-03-22 | 33 | 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