# K043524: Ultrasound Scanner Pro Focus, Model 2202

- Pathway: 510(k) (Special)
- Applicant: B-K Medical A/S
- Decided: Jan 13, 2005 after 24 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: 2 generations back to K000567 (2000). 4 ancestors in all.
88 later devices descend from it; 5 cite it directly.
0 of 93 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.

## Most influential descendants
- K100919: Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 (2011), 82 descendants of its own
- K081154: Ultrasound Scanner Flex Focus, Model 1202 (2008), 76 descendants of its own
- K123254: Ultrasound Scanner Flex Focus (2013), 68 descendants of its own
- K132335: Ultrasound Scanner Flex Focus 1202 (2014), 66 descendants of its own
- K152763: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System (2015), 65 descendants of its own

## Recalls of this device
- Jan 24, 2008 · Not classified · Z-1140-2008: Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization.

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

Source page: https://510kreport.com/device/K043524
Methodology: https://510kreport.com/methodology