# K252237: EdgeFlow UW20

- Pathway: 510(k) (Traditional)
- Applicant: Edgecare, Inc.
- Decided: Apr 17, 2026 after 274 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
Longest line of descent: 7 generations back to K915436 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231677: EdgeFlow UH10, Edgecare, Inc. (2024) Summary page 6.

## Indications for use
The EdgeFlow UW20 is a wearable ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively in adult patients with BMI up to 30. The bladder volume measurements can be performed periodically at a set time interval set by the user. It is intended for use in professional healthcare facilities, such as hospitals and clinics, by qualified and trained healthcare professionals. The EdgeFlow UW20 supports B-mode and harmonic imaging modes.

Source page: https://510kreport.com/device/K252237
Methodology: https://510kreport.com/methodology