# K211746: Pocket Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Youkey Medical Co., Ltd.
- Decided: Feb 18, 2022 after 256 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K935595 (1995). 324 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192107: Clarius Ultrasound Scanner, Clarius Mobile Health Corp. (2019) Summary page 4.

## Most influential descendants
- K231930: Digital Ultrasonic Diagnostic Imaging System (Model: F6) (2024), 0 descendants of its own

## Indications for use
Pocket Ultrasound System(Model:P50,P51,P52,P53,P54,P55,P56) is intended for use by an appropriately trained, qualified physician for ultrasound evaluation. Specific clinical applications and exam types include: Abdominal, Obstetrics, Gynaecology, Small Parts (breast, thyroid), Peripheral Vascular, Urology. The system is suitable for use in hospital and clinical settings.

Source page: https://510kreport.com/device/K211746
Methodology: https://510kreport.com/methodology