510(k) · Cleared
Recalled · Class II · 2025Merge Hemo, Model RCSV2
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 Jun 21, 2024 as substantially equivalent to K152864 (Merge Healthcare Incorporated, 2016) after a 266-day review. Its family tree reaches back 8 generations to 2000. It has been recalled once.
- Decided
- Jun 21, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001305 (2000). 9 ancestors in all. 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 backK152864 Merge HemoMerge Healthcare Incorporated · 2016 · Recalled
- This deviceK233326 Merge Hemo, Model RCSV2Merge Healthcare Incorporated · 2024
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 | K152864 | Merge Hemo | Merge Healthcare Incorporated | 2016 | 2 |
| 0 (this device) | K233326 | Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 11, 2025 | Class II | Z-2518-2025 | Process control | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure Sensor… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 9 ancestors have a recall of any class.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 patients undergoing invasive catheter-based diagnostic and interventional procedures. The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO, 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 12 Lead…
Read the full statement (318 words)
Merge Hemo displays, measures, and records physiological data from patients undergoing invasive
catheter-based diagnostic and interventional procedures.
The Hemo System can visualize and capture vital sign values including ECG, impedance
respiration, SpO, 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 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 (EtCO,) along with apnea and respiration rates calculated from the EtCO, waveforms. The
system can also perform specified calculations from captured or manually entered values.
The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the
Merge Hemo Monitor PC.
All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo
Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual
alarms available in the system alert the operator to anomalous occurrences and facilitate timely
responses.
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 Merge Hemodynamic system is intended for use in invasive catheter-based diagnostic and
interventional procedure laboratories and in pre- and post-procedure care areas in professional
health care facilities. The Merge Hemo system is intended for use under the close supervision of
qualified medical personnel. The system is not intended for unattended patient monitoring or in
situations where arrhythmia detection is required. This system is used in the diagnosis and
treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for
patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under
the direct supervision of physicians, nurses, and technicians.
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/K233326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233326: Merge Hemo, Model RCSV2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233326
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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