# K012203: Clay-Park Labs, Inc. - Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Clay-Park Labs, Inc.
- Decided: Aug 27, 2001 after 45 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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® Lubricating Jelly: named in the summary without a submission number

## Most influential descendants
- K180923: Personal Lubricating Jelly (2018), 0 descendants of its own

## Indications for use
The Clay-Park Labs Lubricating Jelly is indicated for personal lubrication when vaginal dryness causes discomfort and as a lubricant for insertion of rectal thermometers, enemas, douches, and similar types of nozzles.

Source page: https://510kreport.com/device/K012203
Methodology: https://510kreport.com/methodology