# K053397: K-Y Brand Sensual Mist

- Pathway: 510(k) (Special)
- Applicant: Mcneil-Ppc, Inc.
- Decided: Feb 17, 2006 after 73 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) K-Y® Brand Liquid: named in the summary without a submission number

## Indications for use
K-Y® Brand SENSUAL MIST™ is intended as a personal lubricant (for penile and vaginal application) compatible with latex condom.

Source page: https://510kreport.com/device/K053397
Methodology: https://510kreport.com/methodology