# K032305: Omron Intellisense Digital Blood Pressure Monitor, Model Hem-907XL

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Feb 11, 2004 after 201 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.
9 later devices descend from it; 2 cite it directly.
0 of 10 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
- K050233: Omron Non-Invasive Blood Pressure Monitor with Augmentation Index, Model Hem-9000AI (2005), 6 descendants of its own
- K072593: A-Plus Arterial Pulse Waveform Analysis System and PC Software (2007), 4 descendants of its own
- K101002: A-Pulse Caspro Model T7100, a-Pulse Caspal Model T7200 (2010), 2 descendants of its own
- K113185: Model HBP-1300 (2012), 1 descendant of its own
- K260693: VicorderCS (VCS-SYS-1100) (2026), 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 arm circumference ranging from 7 inches to 20 inches (from 17 cm to 50 cm).

Source page: https://510kreport.com/device/K032305
Methodology: https://510kreport.com/methodology