510(k) · Cleared
Recalled · Class II · 2021Merge Hemo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merge Healthcare Incorporated · DQK Computer, Diagnostic, Programmable
Cleared on Apr 7, 2016 as substantially equivalent to K130626 (Ge Medical Systems Information Technologies, Inc., 2013) and 1 other predicate after a 190-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Apr 7, 2016
- Review
- 190 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001305 (2000). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK001305 Mac-Lab System and Cardiolab EP SystemGeneral Electric Medical Systems Information Techn · 2000
- 6 generations backK021366 Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 5 generations backK032577 Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2003
- 4 generations backK050093 Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 3 generations backK061741 Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare · 2006
- 2 generations backK111200 Mac-Lab System, Cardiolab System, Combolab System, Specialslab SystemGE Healthcare · 2011
- 1 generation backK130626 Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology…Ge Medical Systems Information Technologies, Inc. · 2013 · Recalled
- This deviceK152864 Merge HemoMerge Healthcare Incorporated · 2016
- Descendant · cites it directly · 0 of its ownK233326 Merge Hemo, Model RCSV2Merge Healthcare Incorporated · 2024 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K233326Merge Hemo, Model RCSV2Merge Healthcare Incorporated · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001305 | Mac-Lab System and Cardiolab EP System | General Electric Medical Systems Information Techn | 2000 | — |
| −6 | K021366 | Mac-Lab/Cardiolab EP/Combolab | General Electric Medical Systems Information Techn | 2002 | 1 |
| −5 | K032577 | Modification to: Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2003 | — |
| −4 | K050093 | Mac-Lab/Cardiolab EP/Combolab System | Ge Medical Systems Information Technologies | 2005 | 4 |
| −3 | K061741 | Mac-Lab/Cardiolab /Combolab/Specialslab System | GE Healthcare | 2006 | — |
| −2 | K111200 | Mac-Lab System, Cardiolab System, Combolab System, Specialslab System | GE Healthcare | 2011 | — |
| −1 | K130626 | Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording… | Ge Medical Systems Information Technologies, Inc. | 2013 | 1 |
| 0 (this device) | K152864 | Merge Hemo | Merge Healthcare Incorporated | 2016 | — |
| +1 | K233326 | Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 26.7 · 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? (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 |
|---|---|---|---|
| * | K130626 | Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Summary page 4…Programmable Diagnostic Computer (21 CFR 870.1425) Regulatory Class: II Product Code: DQK III. PREDICATE DEVICE GE Mac-Lab, CardioLab, ComboLab, SpecialsLab v6.9.5, K130626 (primary predicate) HeartSuite Hemodynamics, K082421 IV. DEVICE DESCRIPTION Merge Hemo is a hemodynamic recording and displ… | 2013 |
| * | K082421 | Heartsuite Hemodynamics 7.10Summary page 4…gulatory Class: II Product Code: DQK III. PREDICATE DEVICE GE Mac-Lab, CardioLab, ComboLab, SpecialsLab v6.9.5, K130626 (primary predicate) HeartSuite Hemodynamics, K082421 IV. DEVICE DESCRIPTION Merge Hemo is a hemodynamic recording and display system designed to measure, record, and display vi… | 2008 |
| † | K132474 | Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233326 | Merge Hemo, Model RCSV2 | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 23, 2021 | Class II | Z-2387-2021 | Under Investigation by firm | The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x, used in combination with an HL7 lab interface. |
| Apr 6, 2017 | Class II | Z-0350-2018 | Component design/selection | Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K233326 (Merge Healthcare Incorporated, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K130626.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure, The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 12 Lead resting…
Read the full statement (241 words)
Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure,
The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCO2 waveform.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. The two units are connected via a serial interface,
All vital parameters are acquired and calculated in the PDM. This data is then transmitted to the Merge Hemo Monitor PC via the serial interface. All data can then be displayed on the Merge Hemo Monitor PC. The Merge Hemo system is not intended to produce alarms for out-of-range conditions.
Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third party database the Hemo system can display drug to drug or drug to allergy interaction information.
The system is intended for use in hospital cardiac catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152864 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152864: Merge Hemo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152864
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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