# K101241: Replens Long-Lasting Vaginal Moisturizer (Pre-Filled Applicator)

- Pathway: 510(k) (Traditional)
- Applicant: Lil Drug Store Products, Inc.
- Decided: Aug 17, 2010 after 105 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: 3 generations back to K810310 (1981). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062682: CVS Personal Lubricant and Moisturizer, Lake Consumer Products, Inc. (2007) Summary page 1.

## Most influential descendants
- K112217: ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal Moisturizer (2012), 4 descendants of its own
- K143349: Gynomunal (2015), 1 descendant of its own
- K132772: Lubrigyn Cream (2014), 1 descendant of its own
- K232040: Gynatrof (2024), 0 descendants of its own
- K203377: VR101 Lubricating Intravaginal Ring (2021), 0 descendants of its own

## Indications for use
Replens 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 compatible with natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.

Source page: https://510kreport.com/device/K101241
Methodology: https://510kreport.com/methodology