# K091165: Horizon Xvu

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: Aug 7, 2009 after 107 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: 4 generations back to K862740 (1986). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081484: Horizon Xvu, Mennen Medical, Ltd. (2008) Summary page 1.
- K071348: Ems-XL Cardiac Electrophysiology System, Mennen Medical, Ltd. (2007) Summary page 1.

## 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, Intra Cardiac ECG (ICECG), 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/K091165
Methodology: https://510kreport.com/methodology