510(k) · Cleared

Cleared

Quinton Model 710 Stress Electrocardiograph

K945626510(k) TraditionalCleared Jun 28, 1995224-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

Cleared on Jun 28, 1995 after a 224-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 32 later devices descend from it.

Decided: Jun 28, 1995
Review: 224 days
Class: Class II
Product code: DPS
Recalls: None
Predicates: 0

32 later devices descend from it, 2 citing it directly.

This deviceK945626 Quinton Model 710 Stress ElectrocardiographQuinton, Inc. · 1995
Descendant · cites it directly · 29 of its ownK964784 Synergy Cardiology Information System (00431)Quinton, Inc. · 1997
Descendant · 2 generations on · 20 of its ownK032038 Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003
Descendant · 3 generations on · 13 of its ownK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
Descendant · 3 generations on · 8 of its ownK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
Descendant · 4 generations on · 7 of its ownK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

1997high 3 (2015) · low 0 (1998)2026

Most influential descendants

Showing 5 of 32 · See all

K964784Synergy Cardiology Information System (00431)Quinton, Inc. · 1997 · cites it directly29descendants
K032038Pyramis Ecg Management System Model Numbers, 92600 and 92601Quinton, Inc. · 2003 · 2 generations on20descendants
K050858Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · 3 generations on13descendants
K061905Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006 · 3 generations on8descendants
K113515Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945626	Quinton Model 710 Stress Electrocardiograph	Quinton, Inc.	1995	—
+1	K964784	Synergy Cardiology Information System (00431)	Quinton, Inc.	1997	—
+2	K032038	Pyramis Ecg Management System Model Numbers, 92600 and 92601	Quinton, Inc.	2003	—
+3	K050858	Ascentia Heartstation Ecg Management System	Heartlab, Inc.	2005	1
+3	K061905	Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0	Medcon, Ltd.	2006	—
+4	K113515	Horizon Cardiology Ecg Management	Mckesson Israel, Ltd.	2012	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
1999	1	0
2002	2	0
2003	2	0
2005	2	0
2006	1	0
2007	1	0
2011	2	0
2012	2	0
2014	2	0
2015	3	0
2016	3	0
2017	1	0
2018	3	0
2020	2	0
2023	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K945626, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K212112 Cardiologs Holter Platformscore 18.6 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K964784	Synergy Cardiology Information System (00431)	Quinton, Inc.	1997	29
K972310	Nihon Kohden QP-932E Ecg Exercise Test Option for the Nihon Kohden Ecg-9320/a Cardiofax…	Nihon Kohden America, Inc.	1997	1

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, K964784 (Quinton, Inc., 1997) has gone furthest, with 29 descendants of its own.

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

2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	11	87	2	9
2008	13	31	0	17
2009	14	84	1	14
2010	11	104	2	21
2011	22	154	1	121
2012	12	117	0	56
2013	10	134	0	15
2014	11	253	0	15
2015	8	178	0	30
2016	11	229	0	12
2017	9	177	0	15
2018	14	221	0	19
2019	3	178	9	27
2020	6	224	2	59
2021	5	135	1	24
2022	6	244	1	59
2023	10	236	3	54
2024	8	260	4 (1)	64
2025	6	163	3	55
2026	6	258	4	—

https://510kreport.com/device/K945626 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945626: Quinton Model 710 Stress Electrocardiograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945626

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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