# K152646: Sylk Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Toro Management, LLC Dba Sylk
- Decided: Mar 11, 2016 after 177 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: 4 generations back to K810310 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124044: Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants, Seven Oaks Ranch, Inc. (2013) Summary page 4.

## Indications for use
Sylk Personal Lubricant is intended for penile and/or 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 and polyurethane condoms.

Source page: https://510kreport.com/device/K152646
Methodology: https://510kreport.com/methodology