# K123792: Horizon Xvu (FFR)

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: Aug 30, 2013 after 263 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K823434 (1982). 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)
- K041134: Combomap Pressure and Flow System, Volcano Therapeutics, Inc. (2004) Summary page 2.

## Indications for use
The Horizon XVu is a state-of-the-ant computerized laboratory, capable of acquiring and displaying essential patient data such as EGG/Heart Rate, Intra Cardiac EG (IGEG) invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures, and EtCO2. HP waveforms from different heart and vascular sites, are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform, gradients and PER, can be stored, recorded, analyzed and presented in a variety of report formats.

Source page: https://510kreport.com/device/K123792
Methodology: https://510kreport.com/methodology