# K150072: TheyFit Male Condom

- Pathway: 510(k) (Traditional)
- Applicant: Theyfit
- Decided: Apr 14, 2015 after 90 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: 7 generations back to K980964 (1999). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122219: Theyfit Male Condom, Theyfit (2013) Summary page 4.

## 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/K150072
Methodology: https://510kreport.com/methodology