# K991374: Invigra

- Pathway: 510(k) (Abbreviated)
- Applicant: Indus Medicare, Ltd.
- Decided: Jun 15, 1999 after 55 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
- K051273: Divas Dual Pleasure Male Latex Condom (2005), 0 descendants of its own

## Indications for use
The Invigra Condom is used for contraception and for prophytic purposes. Invigra Copdoms when properly used are highly effective against pregnancy and will help to reduce the risk of transmission of HIV infection (AIDS) and many other Sexually Transmitted Diseases (STD), including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphliss. No contraceptive can guarantee 100% effectiveness although condoms are highly effective when properly used.

Source page: https://510kreport.com/device/K991374
Methodology: https://510kreport.com/methodology