# K182481: HEM-6410T-ZM Wrist Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Nov 9, 2018 after 60 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: 4 generations back to K042505 (2005). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163045: Omron HEM-6400T-Z Wrist Blood Pressure Monitor, Omron Healthcare, Inc. (2017) Summary page 5.

## Most influential descendants
- K242568: Wrist Blood Pressure Monitor (OHMS11, OHMS12) (2025), 0 descendants of its own

## Indications for use
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 6.3 inches to 7.5 inches (16.0cm to 19.0cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K182481
Methodology: https://510kreport.com/methodology