# K131905: Solid Gel Pad

- Pathway: 510(k) (Traditional)
- Applicant: Bluemtech
- Decided: Jul 18, 2013 after 22 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: 3 generations back to K961757 (1996). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112827: Sheathes Ultrasond Gel, Sheathing Technologies, Inc. (2012) Summary page 2.
- K121311: Thixo-Gel Ultrasound Spray, Cloverline International Pharma Services GmbH (2012) Summary page 1.

## Most influential descendants
- K252337: EdgeFlow Gel Pad (2026), 0 descendants of its own

## Indications for use
Non-sterile ultrasound couplant for use with medical diagnostic ultrasound. It is intended to be used during non-invasive medical diagnostic ultrasound procedures to couple sound waves between a patient and the medical imaging electronics. The gel is intended for use in all diagnostic ultrasound procedures which require ultrasound coupling gel or liquid or fluid.

Source page: https://510kreport.com/device/K131905
Methodology: https://510kreport.com/methodology