# K261061: BP Go (BPP-855)

- Pathway: 510(k) (Traditional)
- Applicant: Wellvii, Inc.
- Decided: Aug 13, 2026 after 135 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K894563 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081924: Calhealth, Inc., Finger Blood Pressure Monitor, Mdmouse, Calhealth, Inc. (2009) Summary page 5.

## Indications for use
The Wellvii Inc. BP Go™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), and pulse rate from the base of the left index finger. This device is intended for use by persons aged 18 years and older only with a left index finger circumference between 5.1 [em] to 8.0 [cm]. This device is not intended for use in patients with irregular heart rhythms, including atrial fibrillation, patients that are pregnant, or patients with poor peripheral perfusion/peripheral vascular disease.

Source page: https://510kreport.com/device/K261061
Methodology: https://510kreport.com/methodology