# K122219: Theyfit Male Condom

- Pathway: 510(k) (Traditional)
- Applicant: Theyfit
- Decided: Sep 27, 2013 after 429 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
Longest line of descent: 6 generations back to K980964 (1999). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113061: Large/Extra Lagre Condom, Karex Industries Sdn. Bhd. (2011) Summary page 1.
- K081886: Karex Industries Male Natural Rubber Latex Condom, Non-Spermicidal, Lubricated and Non Lubricated, Karex Industries Sdn. Bhd. (2009) Summary page 1.

## Most influential descendants
- K210208: Titan Condoms (2022), 0 descendants of its own
- K150072: TheyFit Male Condom (2015), 0 descendants of its own

## Indications for use
The TheyFit male condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K122219
Methodology: https://510kreport.com/methodology