# K955648: K-Y Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Pharmaceutical Corp.
- Decided: Jun 21, 1996 after 192 days
- Product code: HIS (Condom)
- 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.
95 later devices descend from it; 15 cite it directly.
0 of 96 devices 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® Jelly Personal Lubricant: named in the summary without a submission number
- (no number) ASTROGLIDE® Personal Lubricant: named in the summary without a submission number

## Most influential descendants
- K032124: Durex Play Lubricant (2004), 40 descendants of its own
- K061466: Intimol (2006), 24 descendants of its own
- K042563: Durex Play Warmer Lubricant (2005), 24 descendants of its own
- K124044: Aloe Cadabra Lubricant, Aloe Cadabra Flavored/Scented Lubricants (2013), 23 descendants of its own
- K060098: Durex Play Temptations Assorted Lubricants (2006), 22 descendants of its own

## Indications for use
This device is indicated to enhance the comfort and ease of intimate activity with or without a latex condom. K-Y ® Liquid Personal Lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condom:s to facilitate application or outside for lubrication during intercourse.

Source page: https://510kreport.com/device/K955648
Methodology: https://510kreport.com/methodology