# K101429: Eco Supergel

- Pathway: 510(k) (Traditional)
- Applicant: Ceracarta Spa
- Decided: Sep 15, 2010 after 117 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K082146: Metha Short Stem Hip System XL Femoral Head, Aesculap Implant Systems, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
ECO SUPERGEL® is a transmission gel media used with ultrasonic pulsed echo imaging systems. The gel, when applied on the defined area of the body, facilitates the use of the system, which is intended to project 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.

Source page: https://510kreport.com/device/K101429
Methodology: https://510kreport.com/methodology