# K113085: Tryly Automatic Wrist Blood Pressure Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Truly Instrument Co., Ltd.
- Decided: Jan 12, 2012 after 86 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: 6 generations back to K903134 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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 1.

## Indications for use
Truly Automatic Wrist Blood Pressure Monitor, Models DW801, DW802, DW803, DW805, DW806, DW807, DW808, DW901, DW902, DW903 are a series device 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 display a warning signal with the reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K113085
Methodology: https://510kreport.com/methodology