# K163235: HEM-9210T

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Apr 20, 2017 after 154 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 K052153 (2005). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133379: HEM-7311, Omron Healthcare, Inc. (2014) Summary page 4.

## Most influential descendants
- K201467: Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B (2020), 1 descendant of its own
- K202934: Blood Pressure Monitor (2021), 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. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

Source page: https://510kreport.com/device/K163235
Methodology: https://510kreport.com/methodology