# K043554: Ultrasound Scanner Mini Focus, Model 1402

- Pathway: 510(k) (Special)
- Applicant: B-K Medical A/S
- Decided: Jan 14, 2005 after 18 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: 2 generations back to K000567 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024236: Ultrasound Scanner, Type 2400, B-K Medical A/S (2003) Summary page 1.

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

Source page: https://510kreport.com/device/K043554
Methodology: https://510kreport.com/methodology