510(k) · Cleared
ClearedMac-Lab/Cardiolab /Combolab/Specialslab System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · DQK Computer, Diagnostic, Programmable
Cleared on Sep 15, 2006 as substantially equivalent to K050093 (Ge Medical Systems Information Technologies, 2005) after an 87-day review. Its family tree reaches back 4 generations to 2000. 10 later devices descend from it.
- Decided
- Sep 15, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001305 (2000). 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK001305 Mac-Lab System and Cardiolab EP SystemGeneral Electric Medical Systems Information Techn · 2000
- 3 generations backK021366 Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 2 generations backK032577 Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2003
- 1 generation backK050093 Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2005 · Recalled
- This deviceK061741 Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare · 2006
- Descendant · cites it directly · 8 of its ownK111200 Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare · 2011
- Descendant · 2 generations on · 7 of its ownK130626 Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology…Ge Medical Systems Information Technologies, Inc. · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK082421 Heartsuite Hemodynamics 7.10Emageon, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 1 of its ownK213972 Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX…Ge Healthcare Information Technologies, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK170032 QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM…Fysicon BV · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K111200Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare · 2011 · cites it directly8descendants
- K130626Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Ge Medical Systems Information Technologies, Inc. · 2013 · 2 generations on7descendants
- K082421Heartsuite Hemodynamics 7.10Emageon, Inc. · 2008 · cites it directly2descendants
- K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording…Ge Healthcare Information Technologies, Inc. · 2022 · 3 generations on1descendant
- K170032QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EPFysicon BV · 2017 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001305 | Mac-Lab System and Cardiolab EP System | General Electric Medical Systems Information Techn | 2000 | — |
| −3 | K021366 | Mac-Lab/Cardiolab EP/Combolab | General Electric Medical Systems Information Techn | 2002 | 1 |
| −2 | K032577 | Modification to: Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2003 | — |
| −1 | K050093 | Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2005 | 4 |
| 0 (this device) | K061741 | Mac-Lab/Cardiolab /Combolab/Specialslab System | GE Healthcare | 2006 | — |
| +1 | 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 | K082421 | Heartsuite Hemodynamics 7.10 | Emageon, Inc. | 2008 | 11 |
| +3 | K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab… | Ge Healthcare Information Technologies, Inc. | 2022 | 1 |
| +3 | K170032 | QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO… | Fysicon BV | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K050093 | Mac-Lab/Cardiolab EP/Combolab SystemSummary page 1…n Laboratory System Classification Names: 21 CFR 870.1425 Pro'grammableDiagnosticComputer Predicate Device: Mac-Lab/CardioLab EP/ComboLab System (K050093) Page 12ai (of a-d)… | 2005 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K111200 (GE Healthcare, 2011) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K050093.
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?
Mac-Lab System: The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO₂), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood…
Read the full statement (478 words)
Mac-Lab System:
The Mac-Lab System is intended for monitoring, calculating and recording cardiovascular data from patients undergoing invasive cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO₂), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). The information can be displayed, trended, stored, printed, and or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.)
CardioLab System:
The CardioLab System is intended to acquire, filter, digitize, amplify, display and record the electrical signals. Signal types acquired include ECG signals, direct cardiac signals, temperature, EtCO2 and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and ablation generators (i.e. RF and cryogenic).
The CardioLab System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.
Interfaced devices the system may acquire, amplify, display and record anatomical and physiological data from includes equipment typically used in conjunction with these procedures, such as imaging and data devices (e.g. X-ray, ultrasound, magnetic resonance, computed tomography, positron emission tomography, nuclear medicine, 12 lead ECG and information systems.)
ComboLab System:
The ComboLab System is the combination of the both the Mac-Lab and CardioLab systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System, although only one may be used at a time.
SpecialsLab System:
The SpecialsLab is the same as the Mac-Lab, CardioLab or ComboLab systems. The SpecialsLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. SpecialsLab executes the same software, and runs on the same hardware. Products designated SpecialsLab will support fewer options than the Mac-Lab, CardioLab or ComboLab.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061741 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061741: Mac-Lab/Cardiolab /Combolab/Specialslab System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061741
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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