# K183710: Vivio System

- Pathway: 510(k) (Traditional)
- Applicant: Avicena, LLC
- Decided: Oct 4, 2019 after 277 days
- Product code: DQD (Stethoscope, Electronic)
- Device class: 2
- Regulation: 21 CFR 870.1875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K771653 (1977). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083903: 3M Littmann Electronic Stethoscope, Model 3200, 3M Company (2009) Summary page 5.

## Indications for use
The Vivio System is indicated for low frequency (<200 Hz) or Bell Mode operation to acquire and transmit heart sound data to the tablet/UI (with Avicena App) for calculation of heart rate and display and playback of heart sounds (audio and visual).

Source page: https://510kreport.com/device/K183710
Methodology: https://510kreport.com/methodology