# K140428: Ultrasound Scanner System BK2300

- Pathway: 510(k) (Abbreviated)
- Applicant: B-K Medical Aps
- Decided: May 30, 2014 after 100 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K143298: Ultrasound Scanner System bk2300 (2015), 7 descendants of its own
- K151910: Ultrasound Scanner System BK2300 (2015), 6 descendants of its own
- K161960: bk2300 (2016), 5 descendants of its own
- K180737: Ultrasound Scanner System bk2300 (2018), 2 descendants of its own
- K222441: Ultrasound System 2300 (2022), 1 descendant of its own

## Recalls of this device
- Jun 28, 2016 · Class II · Z-2325-2016: In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that 

Source page: https://510kreport.com/device/K140428
Methodology: https://510kreport.com/methodology