# K113185: Model HBP-1300

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Jan 27, 2012 after 91 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: 1 generation back to K032305 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032305: Omron Intellisense Digital Blood Pressure Monitor, Model Hem-907XL, Omron Healthcare, Inc. (2004) Summary page 1.

## Most influential descendants
- 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 and pediatric (> 3 year old) patient population with arm circumference ranging from 5 inches to 20 inches (from 12 cm to 50 cm) The device also detects the appearance of irregular heartbeats during measurement. Model - HBP- 13 00 for prescriptive use by qualified medical personnel in hospitals, acute care settings, outpatient surgery, healthcare practitioner facilities

Source page: https://510kreport.com/device/K113185
Methodology: https://510kreport.com/methodology