# K151910: Ultrasound Scanner System BK2300

- Pathway: 510(k) (Abbreviated)
- Applicant: Bk Medical Aps
- Decided: Oct 5, 2015 after 84 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000567 (2000). 10 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143298: Ultrasound Scanner System bk2300, Bk Medical Aps (2015) Summary page 28.

## Most influential descendants
- 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
- K173569: Ultrasound System 1300 (2018), 1 descendant of its own
- K231764: Ultrasound System 1300 (2023), 0 descendants 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 

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K151910
Methodology: https://510kreport.com/methodology