# K191052: HyaloGYN Vaginal Moisturizing Suppositories

- Pathway: 510(k) (Traditional)
- Applicant: Fidia Farmaceutici S.P.A.
- Decided: Jan 9, 2020 after 265 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). Our reading of the summary gave K150833, FDA’s number for iHealth Align Gluco-Monitoring System, iHealth BG5… (Andon Health Co, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Hyalo GYN® Vaginal Hydrating Gel”. Summary page 6.

## Indications for use
Hyalo GYN® Vaginal Moisturizing Suppositories are personal lubricants 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. Hyalo GYN® Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Source page: https://510kreport.com/device/K191052
Methodology: https://510kreport.com/methodology