# K231677: EdgeFlow UH10

- Pathway: 510(k) (Traditional)
- Applicant: Edgecare, Inc.
- Decided: Mar 6, 2024 after 271 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: 6 generations back to K915436 (1992). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172356: BladderScan Prime PLUS System, Verathon Incorporated (2017) Summary page 5.

## Most influential descendants
- K252237: EdgeFlow UW20 (2026), 0 descendants of its own

## Indications for use
The EdgeFlow UH1 O is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively. It is intended for use in professional healthcare facilities, such as hospitals, clinics, by qualified and trained healthcare professionals. The EdgeFlow UH1 O supports B-mode and harmonic imaging modes.

Source page: https://510kreport.com/device/K231677
Methodology: https://510kreport.com/methodology