# K020827: K-Y Brand Ultra Gel Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Personal Products Co., Div. of Mcneil Ppc, Inc.
- Decided: Jun 12, 2002 after 90 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.
31 later devices descend from it; 5 cite it directly.
0 of 32 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® Brand LIQUID Personal Lubricant: named in the summary without a submission number

## Most influential descendants
- K041129: Personal Lubricating Gel (2004), 17 descendants of its own
- K051295: I-D Glide (2006), 15 descendants of its own
- K150480: JO H20 Water Based Personal Lubricant (2015), 12 descendants of its own
- K160211: Wet Original Personal Lubricant (2016), 9 descendants of its own
- K051436: Pre' Vaginal Lubricant (2006), 9 descendants of its own

## Indications for use
Personal Lubricant compatible with latex condoms, helps enhance intimacy

Source page: https://510kreport.com/device/K020827
Methodology: https://510kreport.com/methodology