# One

- Location (FDA's records): Boston, MA
- FDA decisions: 2 (2012–2012): 2 510(k) clearances
- Product codes: NUC (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 7 (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
- Personal Products Co.: 1 (https://510kreport.com/company/personal-products)
- Trigg Laboratories, Inc.: 1 (https://510kreport.com/company/trigg-laboratories)

## Firms that cite its devices most
- Reckitt Benckiser, LLC: 2 (https://510kreport.com/company/reckitt-benckiser)
- Thai Nippon Rubber Industry Co., Ltd.: 1 (https://510kreport.com/company/thai-nippon-rubber-industry)
- Biofilm, Inc.: 1 (https://510kreport.com/company/biofilm)
- Bath Concept Cosmetics (Dongguan) Co., Ltd.: 1 (https://510kreport.com/company/bath-concept-cosmetics-dongguan)
- Trigg Laboratories, Inc.: 1 (https://510kreport.com/company/trigg-laboratories)
- The Kama Sutra Company: 1 (https://510kreport.com/company/kama-sutra)

## Its most-cited devices
- K110690: One Personal Lubricant (Silicone) (2012), cited by 5
- K110691: One Personal Lubricant (Water Based) (2012), cited by 2

## Recent decisions
- K110690: One Personal Lubricant (Silicone) (Mar 28, 2012)
- K110691: One Personal Lubricant (Water Based) (Feb 1, 2012)

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