510(k) · Cleared
Recalled · Class II · 2016Heartsuite Hemodynamics 7.10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emageon, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Dec 17, 2008 as substantially equivalent to K061741 (GE Healthcare, 2006) after a 117-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it. It has been recalled 11 times.
- Decided
- Dec 17, 2008
- Review
- 117 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001305 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK001305 Mac-Lab System and Cardiolab EP SystemGeneral Electric Medical Systems Information Techn · 2000
- 4 generations backK021366 Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 3 generations backK032577 Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2003
- 2 generations backK050093 Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 1 generation backK061741 Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare · 2006
- This deviceK082421 Heartsuite Hemodynamics 7.10Emageon, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK152864 Merge HemoMerge Healthcare Incorporated · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK233326 Merge Hemo, Model RCSV2Merge Healthcare Incorporated · 2024 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001305 | Mac-Lab System and Cardiolab EP System | General Electric Medical Systems Information Techn | 2000 | — |
| −4 | K021366 | Mac-Lab/Cardiolab EP/Combolab | General Electric Medical Systems Information Techn | 2002 | 1 |
| −3 | K032577 | Modification to: Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2003 | — |
| −2 | K050093 | Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2005 | 4 |
| −1 | K061741 | Mac-Lab/Cardiolab /Combolab/Specialslab System | GE Healthcare | 2006 | — |
| 0 (this device) | K082421 | Heartsuite Hemodynamics 7.10 | Emageon, Inc. | 2008 | — |
| +1 | K152864 | Merge Hemo | Merge Healthcare Incorporated | 2016 | 2 |
| +2 | K233326 | Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated | 2024 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2024 | 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 26.6 · 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 |
|---|---|---|---|
| * | K061741 | Mac-Lab/Cardiolab /Combolab/Specialslab SystemSummary page 1…emodynamics Common Name: Programmable Diagnostic Computer Classification Name: 21 CFR 870.1425, Cardiovascular Predicate Substantially Equivalent Devices: GE Mac-Lab (K061741) Device Description: HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152864 | Merge Hemo | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2016 | Class II | Z-1778-2017 | Software design | Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording. |
| Apr 4, 2016 | Class II | Z-1457-2017 | Software design | In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation. |
| Mar 28, 2016 | Class II | Z-1091-2017 | Software design | There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC. |
| Mar 10, 2016 | Class II | Z-2707-2017 | Software design | If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which… |
| Oct 26, 2015 | Class II | Z-0554-2016 | Process control | The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house. |
| May 31, 2015 | Class II | Z-1203-2017 | Nonconforming Material/Component | Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure. |
| Mar 30, 2015 | Class II | Z-1923-2017 | Unknown/Undetermined by firm | The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the… |
| Jan 21, 2015 | Class II | Z-2347-2015 | Software design | A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab. |
| Sep 29, 2014 | Class II | Z-0143-2015 | Software design | It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the… |
| Apr 30, 2014 | Class II | Z-0665-2017 | Software design | The application may crash during the cath lab procedure. |
| Jul 2, 2012 | Class II | Z-2341-2016 | Software design | The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K152864 (Merge Healthcare Incorporated, 2016) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K061741.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal C02. The system comprises the Patient…
Read the full statement (210 words)
HeartSuite Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and C02, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal C02.
The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC.
The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 1OV.
The system is intended for use in hospital cardiac catheterization laboratories.
The Monitoring System (comprising the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC) is a medical product of the Class fla (RL 93/42/EWG, Appendix IX).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082421: Heartsuite Hemodynamics 7.10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082421
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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