# K103718: Dynacor Lubrication Gel

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: May 10, 2011 after 140 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

Source page: https://510kreport.com/device/K103718
Methodology: https://510kreport.com/methodology