# K170545: Automatic Wrist Bluetooth Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Truly Instrument, Ltd.
- Decided: Nov 21, 2017 after 270 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: 7 generations back to K001182 (2000). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091415: Truly  Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M, Truly Instrument Co., Ltd. (2009) Summary page 4.
- K161846: Automatic Arm Bluetooth Blood Pressure Monitor, Truly Instrument Limited (2016) Summary page 4.

## Indications for use
Truly Automatic Wrist Bluetooth Blood Pressure Monitor DW702, DW703 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The devices' features include irregular pulse rhythm detection during measurement, and will display an alert signal with the reading when irregular heartbeat is detected. The devices' features include Bluetooth function to transmit data to an external Bluetooth device with wireless communication.

Source page: https://510kreport.com/device/K170545
Methodology: https://510kreport.com/methodology