510(k) · Cleared
ClearedQMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fysicon BV · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Aug 27, 2025 as substantially equivalent to K170032 (Fysicon BV, 2017) and 1 other predicate after a 433-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- Aug 27, 2025
- Review
- 433 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001305 (2000). 43 ancestors in all, the oldest K862740 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK001305 Mac-Lab System and Cardiolab EP SystemGeneral Electric Medical Systems Information Techn · 2000
- 7 generations backK021366 Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 6 generations backK032577 Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2003
- 5 generations backK050093 Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 4 generations backK061741 Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare · 2006
- 3 generations backK111200 Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare · 2011
- 2 generations backK130626 Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology…Ge Medical Systems Information Technologies, Inc. · 2013 · Recalled
- 1 generation backK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017
- This deviceK241766 QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001305 | Mac-Lab System and Cardiolab EP System | General Electric Medical Systems Information Techn | 2000 | — |
| −7 | K021366 | Mac-Lab/Cardiolab EP/Combolab | General Electric Medical Systems Information Techn | 2002 | 1 |
| −6 | K032577 | Modification to: Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2003 | — |
| −5 | K050093 | Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2005 | 4 |
| −4 | K061741 | Mac-Lab/Cardiolab /Combolab/Specialslab System | GE Healthcare | 2006 | — |
| −3 | K111200 | Mac-Lab System, Cardiolab System, Combolab System, Specialslab System | GE Healthcare | 2011 | — |
| −2 | K130626 | Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording… | Ge Medical Systems Information Technologies, Inc. | 2013 | 1 |
| −1 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO… | Fysicon BV | 2017 | — |
| 0 (this device) | K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPSummary page 5…Product Code MWI, DQK Regulatory Class 2 Review Panel Cardiovascular PREDICATE DEVICE Primary Predicate Device K170032, QMAPP® Secondary Predicate K131497, McKesson Cardiology TM Hemo Device DEVICE DESCRIPTION The… | 2017 |
| * | K131497 | Mckesson Cardiology HemoSummary page 5…Regulatory Class 2 Review Panel Cardiovascular PREDICATE DEVICE Primary Predicate Device K170032, QMAPP® Secondary Predicate K131497, McKesson Cardiology TM Hemo Device DEVICE DESCRIPTION The QMAPP® system offers a complete… | 2013 |
| † | K083325 | N-600X with SPD, Oximax N-600X | 2009 |
| † | K150620 | 740 Select | 2015 |
| † | K142244 | Cleo Patient Monitor | 2015 |
| † | K012226 | Monitoring System,Model Argus PB-1000 | 2002 |
| † | K042601 | Capnostat 5 | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 13 of the 43 ancestors have a recall of any class.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), End tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG. QMAPP® provides also clinical data acquisition, medical…
Read the full statement (145 words)
QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), End tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG.
QMAPP® provides also clinical data acquisition, medical image/data processing and analytical assessment.
QMAPP® is intended for use in the areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology.
QMAPP® can be used standalone and in networked environments. The system is intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or send to other devices, such as physiological monitoring system, information management systems, image acquisition/storage devices and other medical devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241766: QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241766
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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