510(k) · Cleared
Recalled · Class II · 2023Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Healthcare Information Technologies, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Feb 17, 2022 as substantially equivalent to K130626 (Ge Medical Systems Information Technologies, Inc., 2013) after a 59-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 17, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001305 (2000). 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 deviceK213972 Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX…Ge Healthcare Information Technologies, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK243540 Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i)…Ge Medical Systems Information Technologies, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…Ge Medical Systems Information Technologies, Inc. · 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) | K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab… | Ge Healthcare Information Technologies, Inc. | 2022 | — |
| +1 | K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL… | Ge Medical Systems Information Technologies, Inc. | 2024 | — |
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? (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 |
|---|---|---|---|
| * | K130626 | Mac-Lab Hemodynamic Recording System; Cardiolab Electrophysiology Recording System…Summary page 7…Device Classification Class II Regulation Number: 21 CFR 870.1425 – Computer, Diagnostic Programmable Product Code: DQK Predicate Device: K130626 – GE’s Mac-Lab, CardioLab, ComboLab, SpecialsLab Recording Systems v6.9.5 Reference Device:… | 2013 |
| † | K191008 | iLab Polaris Multi-Modality Guidance System | 2019 |
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 |
|---|---|---|---|
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 8, 2023 | Class II | Z-2613-2023 | Component design/selection | A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K243540 (Ge Medical Systems Information Technologies, Inc., 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. 2022, 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?
The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements, which may then be displayed, filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations. The CardioLab system is…
Read the full statement (270 words)
The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements, which may then be displayed, filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations.
The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements, which may then be displayed filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations.
The ComboLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. ComboLab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.
The MLCL Client Software is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. MLCL Client Software may be used in a variety of hospital and clinical settings to record, document and/or review hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.
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/K213972 · printed Nov 3, 2026
Cite this page
510(k) Report. “K213972: Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K213972
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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