# Lelo, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 3 (2016–2025): 3 510(k) clearances
- Product codes: HIS (3)
- 510(k) review time since 2016: median 123 days, against 102 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thai Nippon Rubber Industry Public Company Limited.: 1 (https://510kreport.com/company/thai-nippon-rubber-industry-public)

## Recent decisions
- K243421: Lelo Hex Lubricated Natural Rubber Latex Condom (Mar 7, 2025)
- K162511: LELO RESPECT HEX Natural Rubber Latex Condom (Jan 13, 2017)
- K160644: Lelo Hex Natural Rubber Latex Condom (Jun 30, 2016)

Source page: https://510kreport.com/company/lelo