# K011417: Ultrasound Scanner, Type 2102

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical A/S
- Decided: Jun 8, 2001 after 30 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
No predicates in its family tree.
92 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K024236: Ultrasound Scanner, Type 2400 (2003), 91 descendants of its own
- K043524: Ultrasound Scanner Pro Focus, Model 2202 (2005), 88 descendants of its own
- 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

Source page: https://510kreport.com/device/K011417
Methodology: https://510kreport.com/methodology