# K991775: Modification to Computerized Catheterization Laboratory - Horizon 9000 WS

- Pathway: 510(k) (Special)
- Applicant: Mennen Medical, Inc.
- Decided: Jun 24, 1999 after 30 days
- Product code: DXG (Computer, Diagnostic, Pre-Programmed, Single-Function)
- Device class: 2
- Regulation: 21 CFR 870.1435
- 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 K940415 (1995). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940415: Horizon 9000 WS, Mennen Medical, Inc. (1995) Summary page 2.

## Most influential descendants
- K032997: Modification to: Horizon 9000WS (2003), 4 descendants of its own
- K081484: Horizon Xvu (2008), 1 descendant of its own
- K091165: Horizon Xvu (2009), 0 descendants of its own
- K070254: Horizon SE (2007), 0 descendants of its own
- K043564: Horizon Angio Cathlab (2005), 0 descendants of its own

## Indications for use
The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. 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/K991775
Methodology: https://510kreport.com/methodology