# K092488: Dynarex Sterile Lubricating Jelly

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corporation
- Decided: Dec 18, 2009 after 127 days
- Product code: KMJ (Lubricant, Patient)
- Device class: 1
- Regulation: 21 CFR 880.6375
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041060 (2004). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041060: E-Z Lubricating Jelly, Chester Labs, Inc. (2004) Summary page 1.

## Most influential descendants
- K142473: Lubricating Jelly (2015), 0 descendants of its own
- K113689: Dukal Lubricating Jelly (2012), 0 descendants of its own
- K112110: Sterile Lubricating Jelly (2012), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1635-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.

Source page: https://510kreport.com/device/K092488
Methodology: https://510kreport.com/methodology