# K142473: Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Sion Biotext Medical, Ltd.
- Decided: Apr 13, 2015 after 222 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041060 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092488: Dynarex Sterile Lubricating Jelly, Dynarex Corporation (2009) Summary page 5.

## Indications for use
The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.

Source page: https://510kreport.com/device/K142473
Methodology: https://510kreport.com/methodology