# K231288: Vyvo

- Pathway: 510(k) (Traditional)
- Applicant: Vyvo Technology Corp.(Vt)
- Decided: Mar 4, 2024 after 305 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001085 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181006: BB-613 Watch Oximeter, Bio-Beat Technologies, Ltd. (2018) Summary page 5.

## Indications for use
The VYVO Life Watch is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

Source page: https://510kreport.com/device/K231288
Methodology: https://510kreport.com/methodology