# K000681: AU5, AU6

- Pathway: 510(k) (Traditional)
- Applicant: Biosound Esaote, Inc.
- Decided: May 3, 2000 after 65 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.
34 later devices descend from it; 4 cite it directly.
0 of 35 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
- K132466: Mylabseven 6400, Mylabalpha 7400 (2013), 22 descendants of its own
- K142008: Mylabseven, Mylabalpha (2014), 19 descendants of its own
- K153277: 6200 Ultrasound System and 6250 Ultrasound System (2016), 12 descendants of its own
- K163082: 6200 Ultrasound System and 6250 Ultrasound System (2017), 9 descendants of its own
- K173291: 6440 Ultrasound System (2018), 8 descendants of its own

Source page: https://510kreport.com/device/K000681
Methodology: https://510kreport.com/methodology