# K202403: SKORE (Colors & Flavors), SKORE (Colors)

- Pathway: 510(k) (Traditional)
- Applicant: Ttk Healthcare Limited
- Decided: Apr 15, 2021 after 237 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: 1 generation back to K132490 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132490: Skore and Multiple Brands, Ttk Protective Devices Limited (Formerly Ttk-Lig L (2014) Summary page 4.

## Most influential descendants
- K213547: SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla (2021), 0 descendants of its own

## Indications for use
SKORE Red, SKORE Yellow, SKORE Brown, SKORE Orange & SKORE Strawberry, SKORE Cherry, SKORE Banana, SKORE Pinacolada, SKORE Tangerine, SKORE Chocolate and SKORE Cool Mint, Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Source page: https://510kreport.com/device/K202403
Methodology: https://510kreport.com/methodology