# K260693: VicorderCS (VCS-SYS-1100)

- Pathway: 510(k) (Traditional)
- Applicant: 80 Beats Medical GmbH
- Decided: Jun 16, 2026 after 105 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 K032305 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113185: Model HBP-1300, Omron Healthcare, Inc. (2012) Summary page 5.

## Indications for use
VicorderCS is intended for the non-invasive measurement of blood pressure and pulse rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (8 in to 17 in). VicorderCS is not intended for use in patients with severe arrhythmias, including atrial fibrillation. The device is intended for use by trained medical personnel in clinical settings.

Source page: https://510kreport.com/device/K260693
Methodology: https://510kreport.com/methodology