510(k) Report

510(k) · Cleared

Cleared

Pyramis Ecg Management System Model Numbers, 92600 and 92601

K032038510(k) AbbreviatedCleared Sep 5, 200366-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

Quinton, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Sep 5, 2003 as substantially equivalent to K964784 (Quinton, Inc., 1997) after a 66-day review. Its family tree reaches back 2 generations to 1995. 20 later devices descend from it.

Decided
Sep 5, 2003
Review
66 days
Class
Class II
Product code
DQK
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K945626 (1995). 20 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2016: 2 descendants cleared2005: 2 descendants cleared2015: 3 descendants cleared2018: 3 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2014: 1 descendant cleared2024: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant clearedK945626 · Quinton Model 710 Stress Electrocardiograph · Quinton, Inc. · 1995K964784 · Synergy Cardiology Information System (00431) · Quinton, Inc. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 1 descendant K964784 · Synergy Cardiology Information System (00431) · Quinton, Inc. · 1997K945626 · Quinton Model 710 Stress Electrocardiograph · Quinton, Inc. · 19950+5
  1. Root · 2 generations backK945626 Quinton Model 710 Stress ElectrocardiographQuinton, Inc. · 1995
  2. 1 generation backK964784 Synergy Cardiology Information System (00431)Quinton, Inc. · 1997
  3. This deviceK032038 Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003
  4. Descendant · cites it directly · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
  5. Descendant · cites it directly · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
  6. Descendant · 2 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
  7. Descendant · 3 generations on · 6 of its ownK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
  8. Descendant · 4 generations on · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12011: 12012: 22014: 12015: 32016: 22017: 12018: 32020: 12023: 12024: 12025: 1
2005high 3 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 20 · See all
  • K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · cites it directly13descendants
  • K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · cites it directly8descendants
  • K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 2 generations on7descendants
  • K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014 · 3 generations on6descendants
  • K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945626Quinton Model 710 Stress ElectrocardiographQuinton, Inc.1995—
−1K964784Synergy Cardiology Information System (00431)Quinton, Inc.1997—
0 (this device)K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc.2003—
+1K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.20051
+1K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.2006—
+2K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.20122
+3K133534Mckesson Cardiology Ecg MobileMckesson Israel, Ltd.2014—
+4K151774CARESTREAM Vue MotionCarestream Health, Inc.20151

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
201110
201220
201410
201530
201620
201710
201830
202010
202310
202410
202510
FIG. 1 — Lineage of K032038, 1995–2025Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K964784Synergy Cardiology Information System (00431)
Summary page 1
…870.2340 Electrocardiograph (Accessory) 10. The Pyramis ECG Management System is substantially equivalent to the Quinton Synergy Cardiology Information System, CIS (K964784) 1 1. Description. The Pyramis system is a personal computer based, comprehensive data management tool, with multi-tas…
Quinton, Inc.1997—

Also cleared against K964784: 1 other device →

What descends from it? (20)

See all 20

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.200513
K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.20068
K052883CardioserverDatrix20054
K161465CardioConfirmMortara Instrument, Inc.20160

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 8 years and passes through 1 company; a new generation was cleared every 6.1 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K050858 (Heartlab, Inc., 2005) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K964784.

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 system may be used to store, retrieve, edit and report records of biologic origin such as ECG, exercise stress and Holter tests. The system can receive tests from a variety of devices. Data is then available through onscreen display, printer, email, fax, HIS (Hospital Information System) results reporting interface or via customized database queries. Users may view and edit interpretative statements and measurements through the onscreen display. The…

Read the full statement (148 words)

The system may be used to store, retrieve, edit and report records of biologic origin such as ECG, exercise stress and Holter tests.

The system can receive tests from a variety of devices. Data is then available through onscreen display, printer, email, fax, HIS (Hospital Information System) results reporting interface or via customized database queries.

Users may view and edit interpretative statements and measurements through the onscreen display.

The system can calculate multiple QTc metrics based upon acquired ECG data.

The system does not modify the original ECG waveform information, nor does it provide an automated ECG interpretive analysis of the data.

The system is designed to provide information for qualified clinicians responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease.

The system is designed for use in a clinical setting by physicians, nurses, clinical technicians, medical records personnel and medical record transcriptionists.

Indications for use as stated in the FDA summary.

Also cleared against K964784

1 other device cites the same predicate.

  • K982384MercatorHarley Street Software, Ltd. · 1999

More from Quinton, Inc.

164 FDA decisions under this applicant name. See the company

  • K021906Quinton Q-Cath, Model 000460Quinton, Inc. · 2002
  • K003576Q-Tel RMS (Rehabilitation Management System), Model 000503Quinton, Inc. · 20011 recall
  • K001492Quinton Q-Stress, Model 000483Quinton, Inc. · 2000
  • K992908Q-Tel Telemetry System V. 6.0 (ST)Quinton, Inc. · 2000
  • K990866Quinton Medtrack CR Plus TreadmillQuinton, Inc. · 19991 recall

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The DQK category page

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https://510kreport.com/device/K032038 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032038: Pyramis Ecg Management System Model Numbers, 92600 and 92601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032038

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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