# K101952: Konix Ultrasound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa
- Decided: May 27, 2011 after 319 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- 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 K961757 (1996). 1 ancestor in all.
16 later devices descend from it; 3 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961757: Ecogel 100 Ultrasound Gel, Eco-Med Pharmaceuticals, Inc. (1996) Summary page 2.

## Most influential descendants
- K112827: Sheathes Ultrasond Gel (2012), 8 descendants of its own
- K151070: Sonishield 100 Antimicrobial Ultrasound Gel (2016), 5 descendants of its own
- K130041: Sheathes Sterile Ultrasound Gel (2013), 5 descendants of its own
- K181363: EcoVue Sterile and Non-Sterile Ultrasound Gels (2018), 4 descendants of its own
- K163026: Ultra/Phonic Scanning Gel (2018), 1 descendant of its own

## Indications for use
Konix® Ultrasound Gel is intended for general use as a nonsterile transmission media for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.

Source page: https://510kreport.com/device/K101952
Methodology: https://510kreport.com/methodology