# K170797: wettrust D2care

- Pathway: 510(k) (Traditional)
- Applicant: Wettrust Korea Co., Ltd.
- Decided: Dec 6, 2017 after 264 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101241: Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator), Lil Drug Store Products, Inc. (2010) Summary page 4.

## Indications for use
wettrust D2care is a personal lubricant for 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 not compatible with natural rubber latex or polyurethane condoms. This product is compatible with synthetic polyisoprene condoms.

Source page: https://510kreport.com/device/K170797
Methodology: https://510kreport.com/methodology