# K083817: M. Dior Brand

- Pathway: 510(k) (Abbreviated)
- Applicant: Suzhou Colour-Way Enterprise Development Co., Ltd.
- Decided: Sep 16, 2009 after 268 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 K897129 (1990). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071313: Trojan-Enz Brand, Church & Dwight Co., Inc. (2007) Summary page 1.

## Most influential descendants
- K162919: Male Latex Condoms (2017), 3 descendants of its own
- K220576: FAMA Male Latex Condoms (2022), 2 descendants of its own
- K262108: FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MO (2026), 0 descendants of its own
- K232279: LifeStyles NRL Textured Condom (2023), 0 descendants of its own
- K150828: O-RING Condom (2015), 0 descendants of its own

## Indications for use
M. Dior Brand Latex Condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections. The device is for over the counter use.

Source page: https://510kreport.com/device/K083817
Methodology: https://510kreport.com/methodology