# K081484: Horizon Xvu

- Pathway: 510(k) (Special)
- Applicant: Mennen Medical, Ltd.
- Decided: Jun 20, 2008 after 23 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K940415 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032997: Modification to: Horizon 9000WS, Mennen Medical, Ltd. (2003) Summary page 1.

## Most influential descendants
- K091165: Horizon Xvu (2009), 0 descendants of its own

## Indications for use
The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

Source page: https://510kreport.com/device/K081484
Methodology: https://510kreport.com/methodology