# K121311: Thixo-Gel Ultrasound Spray

- Pathway: 510(k) (Traditional)
- Applicant: Cloverline International Pharma Services GmbH
- Decided: Aug 30, 2012 after 121 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 K802146 (1980). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802146: Aquasonic 100 Ultrasound Trans. Gel,, Parker Laboratories, Inc. (1980) Summary page 2.

## Most influential descendants
- K131905: Solid Gel Pad (2013), 1 descendant of its own
- K252337: EdgeFlow Gel Pad (2026), 0 descendants of its own

## Indications for use
Thixo-Gel Ultrasound Spray® is used as an ultrasound coupling medium for diagnostic and therapeutic procedures on external, intact skin for a short duration.

Source page: https://510kreport.com/device/K121311
Methodology: https://510kreport.com/methodology