# K200098: VagiVital Aktivgel

- Pathway: 510(k) (Traditional)
- Applicant: Peptonic Medical AB
- Decided: Nov 10, 2020 after 299 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: 5 generations back to K810310 (1981). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150883: HyaloGYN Vaginal Hydrating Gel, Fidia Farmaceutici S.P.A. (2015) Summary page 4.

## Indications for use
VagiVital Aktivgel 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 polyisoprene condoms. This product is not compatible with natural rubber latex and polyurethane condoms.

Source page: https://510kreport.com/device/K200098
Methodology: https://510kreport.com/methodology