# K211152: Durex Condom with Benzocaine

- Pathway: 510(k) (Traditional)
- Applicant: Rb Health (Us), LLC
- Decided: May 11, 2022 after 387 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 K822088 (1982). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020659: Durex Latex Condom with Male Genital Desensitizer Lubricant, Ssl Americas, Inc. (2002) Summary page 4.

## Most influential descendants
- K230049: SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine; SKORE Bulbous Condoms - SKORE WARM, SKORE COOL; SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT (2023), 0 descendants of its own

## Indications for use
The Durex Condom with Benzocaine 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/K211152
Methodology: https://510kreport.com/methodology