# K061822: Omron Automatic Blood Pressure Monitor with Comfit Cuff, Model Hem 780 N3

- Pathway: 510(k) (Special)
- Applicant: Omron Healthcare, Inc.
- Decided: Aug 2, 2006 after 35 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
No predicates in its family tree.
77 later devices descend from it; 7 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K101681: Transtek Blood Pressure Monitor Model TMB-986, TMB-987, TMB-995 (2011), 21 descendants of its own
- K120058: Transtek Blood Pressure Monitor (2012), 20 descendants of its own
- K123780: Transtek Blood Pressure Monitor (2013), 19 descendants of its own
- K131395: Transtek Blood Pressure Monitor (2013), 18 descendants of its own
- K101242: Genesis DM Model: 6053000A1 (2010), 18 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 arm circumference ranging from 9 inches to 17 inches (22 cm - 42 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. The Omron 780N3 model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Source page: https://510kreport.com/device/K061822
Methodology: https://510kreport.com/methodology