# K850478: PLUS 1

- Pathway: 510(k) (Traditional)
- Applicant: Dymax Corp
- Decided: Apr 15, 1985 after 63 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.
276 later devices descend from it; 1 cites it directly.
2 of 277 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
- K993624: Site-Rite 3 Ultrasound System (1999), 275 descendants of its own
- K032135: Site-Rite IV Ultrasound System (2003), 140 descendants of its own
- K052517: Site-Rite 5 Ultrasound System (2005), 139 descendants of its own
- K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6 (2007), 136 descendants of its own
- K021628: Sonosite Hand-Caried Untrasound System (Powerseries) (2002), 124 descendants of its own

Source page: https://510kreport.com/device/K850478
Methodology: https://510kreport.com/methodology