# K030889: Ultraekogel Models EK 2000 & EK 2001

- Pathway: 510(k) (Traditional)
- Applicant: Inmed Ltda.
- Decided: May 23, 2003 after 63 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.
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)
- K802146: Aquasonic 100 Ultrasound Trans. Gel,, Parker Laboratories, Inc. (1980) Summary page 1.

## Indications for use
ULTRAEKOGELm is an electroconductive gel media used with ultrasonic pulsed echo imaging system. The gel -once applied on the defined area of the body- facilitates the intended 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/K030889
Methodology: https://510kreport.com/methodology