# K252337: EdgeFlow Gel Pad

- Pathway: 510(k) (Traditional)
- Applicant: Edgecare, Inc.
- Decided: Apr 24, 2026 after 270 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: 4 generations back to K961757 (1996). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131905: Solid Gel Pad, Bluemtech (2013) Summary page 6.

## Indications for use
The EdgeFlow Gel Pad is a non-sterile, single-use accessory intended for use exclusively with the EdgeFlow UW20 wearable bladder scanner. The device provides acoustic coupling between the ultrasound transducer and the patient’s intact abdominal skin during bladder ultrasound procedures, enabling transmission of ultrasound signals required for bladder imaging and bladder volume measurement. It is intended for use in professional healthcare facilities, such as hospitals and clinics, by qualified and trained healthcare professionals.

Source page: https://510kreport.com/device/K252337
Methodology: https://510kreport.com/methodology