# K222068: Durex Penck III Regular

- Pathway: 510(k) (Traditional)
- Applicant: Rb Health (Us), LLC
- Decided: Oct 12, 2022 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: 3 generations back to K941258 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200672: Durex Penck Standard, Durex Penck XL, Rb Health (Us), LLC (2020) Summary page 4.

## Indications for use
The Durex Penck III Regular condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs).

Source page: https://510kreport.com/device/K222068
Methodology: https://510kreport.com/methodology