# K021682: Omron Automatic Blood Pressure Monitor with Intellisense, Models Hem-773, Hem-773AC

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Dec 12, 2002 after 204 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 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
- K060504: Ideal Life BP-Manager, Model BPM 0001; Ideal Life Pod, Model Ilp 0001 (2006), 5 descendants of its own
- K080538: Ideal Life Pod (Model Ilp 0001) (2008), 4 descendants of its own
- K041313: Stabil-O-Graph (2004), 3 descendants of its own
- K111932: Iglucose System (2011), 2 descendants of its own
- K130676: Ambio Remote Health Monitoring System (2013), 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 with arm circumference ranging from 9 incties to 17 inches (from 22 cm to 42 cm).

Source page: https://510kreport.com/device/K021682
Methodology: https://510kreport.com/methodology