# K210591: Palm Bladder Scanner - PBSV7.1

- Pathway: 510(k) (Special)
- Applicant: Mianyang Meike Electronic Equipment Co., Ltd.
- Decided: Jun 9, 2021 after 100 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.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191307: Palm Bladder Scanner - PBSV5.1, Mianyang Meike Electronic Equipment Co., Ltd. (2019) Summary page 5.

## Indications for use
Palm Bladder Scanner - PBSV7.1 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Source page: https://510kreport.com/device/K210591
Methodology: https://510kreport.com/methodology