# K802146: Aquasonic 100 Ultrasound Trans. Gel,

- Pathway: 510(k) (Traditional)
- Applicant: Parker Laboratories, Inc.
- Decided: Oct 10, 1980 after 35 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 3 cite it directly.
0 of 16 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
- K072515: Embrace Gel (2007), 10 descendants of its own
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (2012), 8 descendants of its own
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (2015), 6 descendants of its own
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), 4 descendants of its own
- K211193: BD Prevue II Peripheral Vascular Vascular Access System (2021), 2 descendants of its own

## Recalls of this device
- Apr 13, 2017 · Class II · Z-1777-2018: There is a potential for the gel packets to have leaks in the packet seal.

Source page: https://510kreport.com/device/K802146
Methodology: https://510kreport.com/methodology