# K230518: HydraDose Vaginal Suppositories

- Pathway: 510(k) (Traditional)
- Applicant: MD Labs, LLC
- Decided: Jun 23, 2023 after 116 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: 6 generations back to K810310 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213220: Revaree Plus Vaginal Suppositories, Farma-Derma S.R.L. (2022) Summary page 4.

## Indications for use
HydraDose Vaginal Suppositories are 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, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K230518
Methodology: https://510kreport.com/methodology