510(k) Report

510(k) · Cleared

Cleared

Heart Rate Turbulence Analysis Technologies

K042148510(k) TraditionalCleared Dec 3, 2004116-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

Ge Medical Syst. Information Technologies · DQK Computer, Diagnostic, Programmable

Cleared on Dec 3, 2004 as substantially equivalent to K991786 (General Electric Medical Systems Information Techn, 1999) after a 116-day review. Its family tree reaches back 2 generations to 1992.

Decided
Dec 3, 2004
Review
116 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K922171 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorK922171 · Centra II Analysis System · Marquette Electronics, Inc. · 1992K991786 · Mars Unity Workstation with Heart Rate Variability (HRV) Option · General Electric Medical Systems Information Techn · 19991990199520002005
Other ancestors, by generation 2 generations back: 1 other ancestor K991786 · Mars Unity Workstation with Heart Rate Variability (HRV) Option · General Electric Medical Systems Information Techn · 1999K922171 · Centra II Analysis System · Marquette Electronics, Inc. · 19920
  1. Root · 2 generations backK922171 Centra II Analysis SystemMarquette Electronics, Inc. · 1992
  2. 1 generation backK991786 Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn · 1999
  3. This deviceK042148 Heart Rate Turbulence Analysis TechnologiesGe Medical Syst. Information Technologies · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K922171Centra II Analysis SystemMarquette Electronics, Inc.1992—
−1K991786Mars Unity Workstation with Heart Rate Variability (HRV) OptionGeneral Electric Medical Systems Information Techn1999—
0 (this device)K042148Heart Rate Turbulence Analysis TechnologiesGe Medical Syst. Information Technologies2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K042148, 1992–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K991786Mars Unity Workstation with Heart Rate Variability (HRV) Option
Summary page 1
…ommon/Usual ECG Analysis Algorithm Name: Classification Names: 21 CFR 870.1425 Programmable Diagnostic Computer Predicate Device: K991786 MARS Unity Workstation with Heart Rate Variability Option Device Description: The Heart Rate Turbulence Analysis Program is a…
General Electric Medical Systems Information Techn1999—

Also cleared against K991786: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
  • None of the 3 ancestors has a recall.
  • 5 other devices also cite its predicate K991786.

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—

What is it indicated for?

The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk…

Read the full statement (109 words)

The Heart Rate Turbulence Analysis Program is intended for use in a hospital, doctor's office, or clinic environment under the direct supervision of a licensed healthcare practitioner. The intended use of the Heart Rate Turbulence Analysis Program is to analyze ECG signals, provide measurements of Heart Rate Turbulence in patients undergoing cardiovascular disease testing for interpretation by qualified healthcare practitioner for the purposes of risk stratification and prediction of sudden cardiac death. The Heart Rate Turbulence Analysis Program only provides measurements, not interpretations. The Heart Rate Turbulence Analysis Program is to be used in conjunction with the patient's clinical history, symptoms, and other diagnostic tests for final clinical judgment.

Indications for use as stated in the FDA summary.

Also cleared against K991786

5 other devices cite the same predicate.

  • K093141Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2009
  • K051026Mars Holter Analysis WorkstationGe Medical Systems Information Technologies · 2005
  • K042108Vista PlusNovacor · 2005
  • K040313HRV ToolsDel Mar Reynolds Medical, Ltd. · 2004
  • K021230HEROMedical Decision Networks · 2003

More from Ge Medical Syst. Information…

2 FDA decisions under this applicant name. See the company

  • K090212Mac 800 Resting Ecg Analysis SystemGe Medical Syst. Information Technologies · 20091 recall

Recent decisions in DQK

The DQK category page

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  • K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific · 2026
  • K262005Affera Integrated Mapping SystemMedtronic, Inc. · 2026

https://510kreport.com/device/K042148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042148: Heart Rate Turbulence Analysis Technologies.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042148

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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