Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtech Products , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
281 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063401 | BANANA RIBBED | Medtech Products , Ltd. | 2007-03-26 | 137 | 0 |
| K012969 | DOUBLE SPRINGERS NONOXNOL 9 CONDOM | Medtech Products , Ltd. | 2002-06-12 | 281 | 0 |
| K993733 | LOVE LOCKERS | Medtech Products , Ltd. | 2000-03-20 | 137 | 0 |
| K993735 | DOUBLE SPRINGERS | Medtech Products , Ltd. | 2000-03-20 | 137 | 0 |
| K993737 | MIGHTY MAN (DYNAMIC LINKERS) | Medtech Products , Ltd. | 2000-03-20 | 137 | 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