510(k) · Cleared

Cleared

Holter for Windows

K930564510(k) TraditionalCleared Apr 19, 1995805-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

North East Monitoring, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Apr 19, 1995 after an 805-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 47 later devices descend from it.

Decided: Apr 19, 1995
Review: 805 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 0

47 later devices descend from it, 5 citing it directly.

This deviceK930564 Holter for WindowsNorth East Monitoring, Inc. · 1995
Descendant · cites it directly · 35 of its ownK042463 Holter PlusRozinn Electronics, Inc. · 2004
Descendant · 2 generations on · 32 of its ownK091075 Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009
Descendant · 3 generations on · 31 of its ownK142681 ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014
Descendant · 4 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
Descendant · 5 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2004high 6 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 47 · See all

K042463Holter PlusRozinn Electronics, Inc. · 2004 · cites it directly35descendants
K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009 · 2 generations on32descendants
K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014 · 3 generations on31descendants
K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 4 generations on30descendants
K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 5 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930564	Holter for Windows	North East Monitoring, Inc.	1995	—
+1	K042463	Holter Plus	Rozinn Electronics, Inc.	2004	—
+2	K091075	Zeus (Zio Ecg Utilization Service) System	iRhythm Technologies, Inc.	2009	—
+3	K142681	ZEUS (ZIO ECG Utilization Service) System	iRhythm Technologies, Inc.	2014	—
+4	K143513	ZIO SR ECG Monitoring Service	iRhythm Technologies, Inc.	2015	—
+5	K163512	Zio AT ECG Monitoring System	iRhythm Technologies, Inc.	2017	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	1	0
2006	1	0
2007	1	0
2008	1	0
2009	1	0
2013	1	0
2014	1	0
2015	3	0
2017	4	0
2018	2	0
2019	1	0
2020	2	0
2021	1	0
2022	5	0
2023	3	0
2024	6	0
2025	5	0
2026	5	0

FIG. 1 — Lineage of K930564, 1995–2026Source: 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 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 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K042463	Holter Plus	Rozinn Electronics, Inc.	2004	35
K051471	Cardioday	Getemed Medizin- Und Informationstechnik AG	2005	4
K042002	Synescope, Easyscope, Synecom, Holterreader	Ela Medical, Inc.	2004	3
K042799	QRS-Card Cardiology Suite	Pulse Biomedical, Inc.	2004	1
K081861	Holter LX Analysis	North East Monitoring, Inc.	2008	0

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, K042463 (Rozinn Electronics, Inc., 2004) has gone furthest, with 35 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

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

https://510kreport.com/device/K930564 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930564: Holter for Windows.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930564

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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