# K163045: Omron HEM-6400T-Z Wrist Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Feb 21, 2017 after 113 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: 3 generations back to K042505 (2005). 4 ancestors in all.
2 later devices descend 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)
- K142917: BP652N (Hem-6300-Z), Omron Healthcare, Inc. (2014) Summary page 5.

## Most influential descendants
- K182481: HEM-6410T-ZM Wrist Blood Pressure Monitor (2018), 1 descendant of its own
- 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 inches to 8 inches (15.0 cm to 20.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K163045
Methodology: https://510kreport.com/methodology