# K250488: Cerynë Intimate Care

- Pathway: 510(k) (Traditional)
- Applicant: Ansella Therapeutics
- Decided: Dec 12, 2025 after 296 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 K122477 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122477: Lifestyles Luxe Premium Personal Lubricant, Ansell Healthcare Products, LLC (2013) Summary page 5.

## Indications for use
Ceryne Intimate Care is a silicone-based 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, and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K250488
Methodology: https://510kreport.com/methodology