510(k) Report

510(k) · Cleared

Cleared

Synergy Cardiology Information System (00431)

K964784510(k) TraditionalCleared Aug 13, 1997259-day reviewClass II21 CFR 870.2340

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

Quinton, Inc. · DPS Electrocardiograph

Cleared on Aug 13, 1997 as substantially equivalent to K945626 (Quinton, Inc., 1995) after a 259-day review. Its family tree reaches back 1 generation to 1995. 29 later devices descend from it.

Decided
Aug 13, 1997
Review
259 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K945626 (1995). 29 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared1999: 1 descendant cleared2006: 1 descendant cleared2016: 3 descendants cleared2005: 2 descendants cleared2002: 2 descendants cleared2011: 2 descendants cleared2015: 3 descendants cleared2018: 3 descendants cleared2012: 2 descendants cleared2014: 2 descendants cleared2024: 1 descendant cleared2017: 1 descendant cleared2020: 2 descendants cleared2025: 1 descendant cleared2023: 1 descendant clearedK945626 · Quinton Model 710 Stress Electrocardiograph · Quinton, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 7 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K945626 · Quinton Model 710 Stress Electrocardiograph · Quinton, Inc. · 19950+5
  1. Root · 1 generation backK945626 Quinton Model 710 Stress ElectrocardiographQuinton, Inc. · 1995
  2. This deviceK964784 Synergy Cardiology Information System (00431)Quinton, Inc. · 1997
  3. Descendant · cites it directly · 20 of its ownK032038 Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003
  4. Descendant · 2 generations on · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
  5. Descendant · 2 generations on · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
  6. Descendant · 3 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
  7. Descendant · cites it directly · 7 of its ownK982384 MercatorHarley Street Software, Ltd. · 1999

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

1999: 12002: 22003: 22005: 22006: 12011: 22012: 22014: 22015: 32016: 32017: 12018: 32020: 22023: 12024: 12025: 1
1999high 3 (2015) · low 0 (2000)2026

Most influential descendants

Showing 5 of 29 · See all
  • K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003 · cites it directly20descendants
  • K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · 2 generations on13descendants
  • K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · 2 generations on8descendants
  • K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 3 generations on7descendants
  • K982384MercatorHarley Street Software, Ltd. · 1999 · cites it directly7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945626Quinton Model 710 Stress ElectrocardiographQuinton, Inc.1995—
0 (this device)K964784Synergy Cardiology Information System (00431)Quinton, Inc.1997—
+1K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc.2003—
+2K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc.20051
+2K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd.2006—
+3K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd.20122
+1K982384MercatorHarley Street Software, Ltd.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200220
200320
200520
200610
201120
201220
201420
201530
201630
201710
201830
202020
202310
202410
202510
FIG. 1 — Lineage of K964784, 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 DPS? 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 DPS device

  1. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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
*K945626Quinton Model 710 Stress Electrocardiograph
Summary page 1
…edicate Device The legally marketed device to which we claim equivalence is the Model Q710 Exercise and Resting Electrocardiograph. The 510(k) number for this device is K945626. 000062 Quinton Instrument Company 510k Notification - K964784 Synergy Cardiology Information System C. Device…
Quinton, Inc.1995—

Also cleared against K945626: 1 other device →

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc.200320
K982384MercatorHarley Street Software, Ltd.19997

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?

  • Its one ancestor has no recall.
  • Of its descendants, K032038 (Quinton, Inc., 2003) has gone furthest, with 20 descendants of its own.
  • 1 other device also cites its predicate K945626.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

The intended use of the Quinton Synergy Cardiolagy Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. (Hence, the CIS would only operate as non-real time system.) Additionally, the CIS may acquire, store, and display administrative data, as patient demographic information.

Acquired information may be reviewed, edited, abridged, or re-formatted and distributed electronically or printed.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K945626

1 other device cites the same predicate.

  • K972310Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax ElectrocardiographNihon Kohden America, Inc. · 1997

More from Quinton, Inc.

164 FDA decisions under this applicant name. See the company

  • K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003
  • 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

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https://510kreport.com/device/K964784 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964784: Synergy Cardiology Information System (00431).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964784

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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