# K141718: Internal Hydrating Gel

- Pathway: 510(k) (Traditional)
- Applicant: Combe Incorporated
- Decided: Nov 13, 2014 after 141 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: 4 generations back to K810310 (1981). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K094039: Hyalo Gyn, Fidia Farmaceutici S.P.A. (2010) Summary page 5.

## Most influential descendants
- K150615: Vaginal Moisturizing Gel (2015), 1 descendant of its own
- K171855: External Moisturizing Gel (2017), 0 descendants of its own

## Indications for use
The device 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 polyisoprene condoms. This device is not compatible with natural rubber latex or polyurethane condoms.

Source page: https://510kreport.com/device/K141718
Methodology: https://510kreport.com/methodology