# K200672: Durex Penck Standard, Durex Penck XL

- Pathway: 510(k) (Traditional)
- Applicant: Rb Health (Us), LLC
- Decided: Nov 6, 2020 after 238 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: 2 generations back to K941258 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163107: Lifestyles Zero Lubricated Latex Male Condom, Ansell Healthcare Products, LLC (2017) Summary page 4.

## Most influential descendants
- K213647: Durex Patronus Wide (2022), 1 descendant of its own
- K220489: Durex Patronus CloseFit, Durex Patronus Regular (2022), 0 descendants of its own
- K222068: Durex Penck III Regular (2022), 0 descendants of its own

## Indications for use
The Durex Penck Standard Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections, STIs). The Durex Penck XL 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/K200672
Methodology: https://510kreport.com/methodology