# K133383: HEM-7320

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Mar 4, 2014 after 120 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: 2 generations back to K052153 (2005). 3 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3, Omron Healthcare, Inc. (2006) Summary page 1.
- K121932: Hem-7200-Z (BP742), Omron Healthcare, Inc. (2012) Summary page 1.

## Most influential descendants
- K170605: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D (2018), 11 descendants of its own
- K200939: Electronic Blood Pressure Monitor (2020), 6 descendants of its own
- K162092: Evolv Model BP7000 Upper Arm Blood Pressure Monitor (2016), 3 descendants of its own
- K223170: Electronic Blood Pressure Monitor, model: HTD6602US (2023), 1 descendant of its own
- K193456: Arm Blood Pressure Monitor (2020), 1 descendant 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/K133383
Methodology: https://510kreport.com/methodology