# K201186: KY Grosz Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Rb Health (Us), LLC
- Decided: Jul 30, 2020 after 90 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K183302 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183302: KY Banksy Aloe, Rb Health (Us), LLC (2019) Summary page 4.

## Most influential descendants
- K200730: pjur WOMAN Nude pjur med SENSITIVE glide (2020), 0 descendants of its own

## Recalls of this device
- Jun 23, 2022 · Class II · Z-1547-2022: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

## Indications for use
This product is intended for penile, vaginal and/or anal application 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/K201186
Methodology: https://510kreport.com/methodology