# K993403: Remed Male Tutti Frutti Condom (Strawberry) Preventor, Lucky Boy, Summit

- Pathway: 510(k) (Abbreviated)
- Applicant: Remed Pharma
- Decided: Aug 18, 2000 after 315 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K023176: Undus Male Latex Condom (with Flavoring) (2002), 0 descendants of its own

## Indications for use
The Remed Preventor Strawberry Tutti Frutti Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Strawberry Tutti Frutti condom is a parallel sided, plain surfaced condom with strawberry flavor and no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

Source page: https://510kreport.com/device/K993403
Methodology: https://510kreport.com/methodology