Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtech Intl., Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
289 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K920876 | CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER | Medtech Intl., Inc. | 1992-12-11 | 289 | 0 |
| K853843 | IV MATE | Medtech Intl., Inc. | 1986-01-09 | 115 | 0 |
| K791462 | HYPERDERMIC NEEDLE WITH SENSOR #514 | Medtech Intl., Inc. | 1979-09-24 | 70 | 0 |
| K790389 | GAUZE & COTTON SPONGES | Medtech Intl., Inc. | 1979-03-26 | 28 | 0 |
| K790467 | SURGICAL EYE SPONGE | Medtech Intl., Inc. | 1979-03-26 | 21 | 0 |
| K781157 | STIMULATOR, NERVE, TRANSCUTANEOUS | Medtech Intl., Inc. | 1978-09-20 | 77 | 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