Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Manexim Multicorp, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
52 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K863707 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40 | Manexim Multicorp, Ltd. | 1986-09-26 | 3 | 0 |
| K863706 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50 | Manexim Multicorp, Ltd. | 1986-09-26 | 3 | 0 |
| K851292 | LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20 | Manexim Multicorp, Ltd. | 1985-05-23 | 52 | 0 |
| K851290 | LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10 | Manexim Multicorp, Ltd. | 1985-05-22 | 51 | 0 |
| K851291 | LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 | Manexim Multicorp, Ltd. | 1985-05-22 | 51 | 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