# K102637: Dynarex Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corporation
- Decided: Feb 16, 2011 after 155 days
- Product code: MUI (Media, Coupling, Ultrasound)
- Device class: 2
- Regulation: 21 CFR 892.1570
- 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 K841871 (1985). 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)
- K841871: Liqua-Sonic Gel, Chester Labs, Inc. (1985) Summary page 1.

## Indications for use
Dynarex Ultrasound Gel is intended for use as an ultrasound coupling media for use with the any Ultrasound System, Ultrasound procedures including diagnostic and elective pre-natal scans. Dynarex Ultrasound Gel is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel is intended to facilitate projecting a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. Apply the ultrasound gel to the treatment area. Remove after treatment with a tissue or towel. For external use only. Contraindications: Not for use with defibrillators.

Source page: https://510kreport.com/device/K102637
Methodology: https://510kreport.com/methodology