510(k) Report

510(k) · Cleared

Cleared

Mac-Lab System and Cardiolab EP System

K001305510(k) TraditionalCleared Jun 27, 200064-day reviewClass II21 CFR 870.1425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

General Electric Medical Systems Information Techn · DQK Computer, Diagnostic, Programmable

Cleared on Jun 27, 2000 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it.

Decided
Jun 27, 2000
Review
64 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
0

31 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2003: 1 descendant cleared2005: 1 descendant cleared2012: 1 descendant cleared2006: 1 descendant cleared2010: 1 descendant cleared2014: 2 descendants cleared2011: 1 descendant cleared2008: 1 descendant cleared2018: 3 descendants cleared2013: 2 descendants cleared2015: 1 descendant cleared2023: 2 descendants cleared2016: 2 descendants cleared2025: 3 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK001305 Mac-Lab System and Cardiolab EP SystemGeneral Electric Medical Systems Information Techn · 2000
  2. Descendant · cites it directly · 30 of its ownK021366 Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn · 2002 · Recalled
  3. Descendant · 2 generations on · 29 of its ownK032577 Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2003
  4. Descendant · 3 generations on · 15 of its ownK050093 Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2005 · Recalled
  5. Descendant · 3 generations on · 12 of its ownK113811 V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012
  6. Descendant · 4 generations on · 10 of its ownK061741 Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare · 2006

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12005: 12006: 12008: 12010: 12011: 12012: 12013: 22014: 22015: 12016: 22017: 12018: 32019: 12020: 12021: 12022: 12023: 22024: 22025: 32026: 1
2002high 3 (2018) · low 0 (2004)2026

Most influential descendants

Showing 5 of 31 · See all
  • K021366Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn · 2002 · cites it directly30descendants
  • K032577Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2003 · 2 generations on29descendants
  • K050093Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies · 2005 · 3 generations on15descendants
  • K113811V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division · 2012 · 3 generations on12descendants
  • K061741Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare · 2006 · 4 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001305Mac-Lab System and Cardiolab EP SystemGeneral Electric Medical Systems Information Techn2000—
+1K021366Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn20021
+2K032577Modification to: Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies2003—
+3K050093Mac-Lab/Cardiolab EP/Combolab SystemGe Medical Systems Information Technologies20054
+3K113811V2.6 Software for the Labsystem Pro EP Recording SystemC.R. Bard Inc., Bard Electrophysiology Division2012—
+4K061741Mac-Lab/Cardiolab /Combolab/Specialslab SystemGE Healthcare2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200510
200610
200810
201010
201110
201210
201320
201420
201510
201620
201710
201830
201910
202010
202110
202210
202320
202420
202530
202610
FIG. 1 — Lineage of K001305, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (31)

See all 31

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K021366Mac-Lab/Cardiolab EP/CombolabGeneral Electric Medical Systems Information Techn200230

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?

  • Of its descendants, K021366 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 30 descendants of its own.

How does its category compare?

All DQK devices

DQK 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

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

More from General Electric Medical Systems…

33 FDA decisions under this applicant name. See the company

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  • K021454Unity Network IDGeneral Electric Medical Systems Information Techn · 2002
  • K020290Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 20021 recall

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https://510kreport.com/device/K001305 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001305: Mac-Lab System and Cardiolab EP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001305

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026