# K110690: One Personal Lubricant (Silicone)

- Pathway: 510(k) (Abbreviated)
- Applicant: One
- Decided: Mar 28, 2012 after 383 days
- Product code: NUC (Lubricant, Personal)
- 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 K062796 (2006). 1 ancestor in all.
13 later devices descend from it; 5 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062796: K-Y Brand Intrigue, Personal Products Co. (2006) Summary page 1.

## Most influential descendants
- K130012: Wet Platinum Personal Lubricant (2013), 6 descendants of its own
- K141913: Pjur Silicone Based Lubricant: Pjur Backdoor Anal Glide and Analyse ME! (2015), 2 descendants of its own
- K191654: SILICONE Personal Lubricant (2020), 1 descendant of its own
- K163395: Astroglide Diamond Silicone Gel Personal Lubricant (2017), 1 descendant of its own
- K211967: Sensual Massage, Ultra Pure (2021), 0 descendants of its own

## Indications for use
ONE® SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

Source page: https://510kreport.com/device/K110690
Methodology: https://510kreport.com/methodology