# K243421: Lelo Hex Lubricated Natural Rubber Latex Condom

- Pathway: 510(k) (Traditional)
- Applicant: Lelo, Inc.
- Decided: Mar 7, 2025 after 123 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 K210294 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210294: One Touch Spiral Condom, Thai Nippon Rubber Industry Public Company Limited. (2021) Summary page 5.

## Indications for use
The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Source page: https://510kreport.com/device/K243421
Methodology: https://510kreport.com/methodology