# K091415: Truly  Automatic Wrist Blood Pressure Monitor, Model DW100,DW200, DW500,DW700,DW703,DW701M.702M

- Pathway: 510(k) (Abbreviated)
- Applicant: Truly Instrument Co., Ltd.
- Decided: Sep 4, 2009 after 114 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: 5 generations back to K903134 (1991). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014141: Digibio Digtial Blood Pressure Monitor Model D11, Digibio Technology Corp. (2002) Summary page 1.
- K073398: Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100), Microlife Corp. (2007) Summary page 1.

## Most influential descendants
- K170545: Automatic Wrist Bluetooth Blood Pressure Monitor (2017), 0 descendants of its own
- K113085: Tryly Automatic Wrist Blood Pressure Monitor (2012), 0 descendants of its own

## Indications for use
Truly Automatic Wrist Blood Pressure Monitor ,Models DW100, 00, MM DW500, DW700, DW701M, DW702M, DW703 are a series devices 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 includeirregiular pulse thyth~m detection during measurefment, and display a warning signal with the'reading once the irregular heartbeat is detected.

Source page: https://510kreport.com/device/K091415
Methodology: https://510kreport.com/methodology