510(k) · Cleared
Recalled · Class II · 2024Windsurfer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcon, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on May 4, 2005 as substantially equivalent to K013032 (Camtronics, Ltd., 2002) after a 62-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it. It has been recalled 4 times.
- Decided
- May 4, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950436 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950436 Witt Biomedical Series IVWitt Biomedical Corporation · 1995
- 1 generation backK013032 Physiolog, Series 95000Camtronics, Ltd. · 2002
- This deviceK050561 WindsurferMedcon, Ltd. · 2005
- Descendant · cites it directly · 3 of its ownK131497 Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017
- Descendant · 2 generations on · 0 of its ownK241766 QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025
- Descendant · 2 generations on · 0 of its ownK230881 Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd. · 2023 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K131497Mckesson Cardiology HemoMckesson Israel, Ltd. · 2013 · cites it directly3descendants
- K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV · 2017 · 2 generations on1descendant
- K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025 · 2 generations on0descendants
- K230881Change Healthcare Cardiology Hemodynamics™Change Healthcare Israel, Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950436 | Witt Biomedical Series IV | Witt Biomedical Corporation | 1995 | — |
| −1 | K013032 | Physiolog, Series 95000 | Camtronics, Ltd. | 2002 | — |
| 0 (this device) | K050561 | Windsurfer | Medcon, Ltd. | 2005 | — |
| +1 | K131497 | Mckesson Cardiology Hemo | Mckesson Israel, Ltd. | 2013 | 10 |
| +2 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO… | Fysicon BV | 2017 | — |
| +2 | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025 | — |
| +2 | K230881 | Change Healthcare Cardiology Hemodynamics™ | Change Healthcare Israel, Ltd. | 2023 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013032 | Physiolog, Series 95000 | 2002 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131497 | Mckesson Cardiology Hemo | 2013 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2024 | Class II | Z-0127-2025 | Use error | 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 inappropriate treatment. This issue occurs… |
| Apr 15, 2010 | Not classified | Z-1974-2010 | Software change control | 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 physiological parameters on the Horizon Cariology… |
| Jan 27, 2010 | Not classified | Z-1899-2010 | Software design | 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 Cardiology Hemo screen and on the… |
| Nov 12, 2007 | Not classified | Z-0710-2008 | Nonconforming Material/Component | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131497 (Mckesson Israel, Ltd., 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050561 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050561: Windsurfer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050561
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026