Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Med-Tech Develoment Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
14 daysmedian FDA review time
21 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860852 | SAPPHIRE BLADE SURGICAL KNIFE | Med-Tech Develoment Corp. | 1986-03-28 | 21 | 0 |
| K860332 | DIAMOND BLADE MICROMETER KNIFE | Med-Tech Develoment Corp. | 1986-02-13 | 15 | 0 |
| K860329 | FYODOROV RADIAL KERATOTOMY MARKER SET | Med-Tech Develoment Corp. | 1986-02-12 | 14 | 0 |
| K860331 | DISPOSABLE SURGICAL KNIFE | Med-Tech Develoment Corp. | 1986-02-12 | 14 | 0 |
| K860330 | MAKLAKOV STYLE TONOMETER | Med-Tech Develoment Corp. | 1986-02-12 | 14 | 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