# K130229: Palm Bladder Scanner

- Pathway: 510(k) (Abbreviated)
- Applicant: Mianyang Meike Electronic Equipment Co., Ltd.
- Decided: Mar 20, 2013 after 50 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: 4 generations back to K915436 (1992). 6 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 1.

## Most influential descendants
- K172750: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) (2018), 4 descendants of its own
- K211321: Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) (2022), 1 descendant of its own
- K191307: Palm Bladder Scanner - PBSV5.1 (2019), 1 descendant of its own
- K260111: Palmtop Ultrasound Diagnostic System (MT10P/MT10) (2026), 0 descendants of its own
- K220169: SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) (2022), 0 descendants of its own

## Indications for use
Abdomen, B-Mode, per Indications for Use Ultrasound Form PBSV4. I bladder scanner 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.

Source page: https://510kreport.com/device/K130229
Methodology: https://510kreport.com/methodology