# K993737: Mighty Man (Dynamic Linkers)

- Pathway: 510(k) (Abbreviated)
- Applicant: Medtech Products, Ltd.
- Decided: Mar 20, 2000 after 137 days
- Product code: HIS (Condom)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Pleasure Plus: named in the summary without a submission number
- (no number) Lifestyle Xtra Pleasure: named in the summary without a submission number

## Indications for use
Mighty Man (Dynamic Linkers) condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.

Source page: https://510kreport.com/device/K993737
Methodology: https://510kreport.com/methodology