# K050561: Windsurfer

- Pathway: 510(k) (Traditional)
- Applicant: Medcon, Ltd.
- Decided: May 4, 2005 after 62 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950436 (1995). 2 ancestors in all.
4 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)
- K013032: Physiolog, Series 95000, Camtronics, Ltd. (2002)

## Most influential descendants
- K131497: Mckesson Cardiology Hemo (2013), 3 descendants of its own
- K170032: QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (2017), 1 descendant of its own
- K241766: QMAPP®  (Hemo, Hemo Lite, PCM, GO, Hybrid) (2025), 0 descendants of its own
- K230881: Change Healthcare Cardiology Hemodynamics™ (2023), 0 descendants of its own

## Recalls of this device
- Aug 21, 2024 · Class II · Z-0127-2025: A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can lead to inaccurate hemodynamic calculations, potentially resulting in misdiagnosis and inappro
- Apr 15, 2010 · Not classified · Z-1974-2010: McKesson has recently discovered that certain Horizon Cardiology Hemo systems were running specific Schiller Argus-Pro PB 1000 firmware versions that might cause a delay in the display of physiologica
- Jan 27, 2010 · Not classified · Z-1899-2010: McKesson has identified a potential hardware configuration problem in some Horizon Cardiology Hemo systems which may cause delay and/or loss of the patient's physiological parameters on the Horizon Ca
- Nov 12, 2007 · Not classified · Z-0710-2008: Power supply reliability: McKesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.

## Indications for use
The Windsurfer is a system for acquiring, digitizing, storing, displaying and reviewing hemodynamic data (vital signs). The Windsurfer is intended for use in hospital cardiac catheterization laboratories.

Source page: https://510kreport.com/device/K050561
Methodology: https://510kreport.com/methodology