# K171668: Bluetooth blood pressure monitor

- Pathway: 510(k) (Traditional)
- Applicant: Visiomed Group SA
- Decided: Feb 26, 2018 after 266 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: 9 generations back to K001670 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133125: Withings Blood Presure Monitor, Withings (2014) Summary page 4.

## Indications for use
BW-BA1 Bluetooth Blood Pressure Monitor is intended to be used to measure systolic and diastolic blood pressure and heart rate from the upper arm with arm circumference ranging from 8.7 inches to 16.5 inches (approx.22 cm to 42 cm) using the oscillometric method. The device detects the appearance of irregular heartbeats during measurement and gives a "IHB" warning signal with readings. The intended patient population of the device is only adult population aged 18 or older at home, not applied to the other populations such as neonatal baby. It cannot be used while the arm has bleeding or wound to avoid the blood flowing from the wound in pressurizing. The device cannot be used by pregnant patients or patients suffering from pre-eclampsia.

Source page: https://510kreport.com/device/K171668
Methodology: https://510kreport.com/methodology