# K070623: Pharmapac Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Pharmapac, LLC
- Decided: Aug 31, 2007 after 178 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: 1 generation back to K810310 (1981). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810310: K-Y Lubricating Jelly, Johnson & Johnson Professionals, Inc. (1981) Summary page 1.

## Indications for use
Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.

Source page: https://510kreport.com/device/K070623
Methodology: https://510kreport.com/methodology