510(k) · Cleared

Cleared

QRS-Card Cardiology Suite

K042799510(k) TraditionalCleared Oct 22, 200414-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

Pulse Biomedical, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Oct 22, 2004 as substantially equivalent to K930564 (North East Monitoring, Inc., 1995) and 4 other predicates after a 14-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.

Decided: Oct 22, 2004
Review: 14 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K881905 (1988). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK881905 Model Micro SI Ambulatory Ecg MonitorAdvanced Medical Products, Inc. · 1988
This deviceK042799 QRS-Card Cardiology SuitePulse Biomedical, Inc. · 2004
Descendant · cites it directly · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all

K142352CardiacLinxRoss Medical Technology, Inc. · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881905	Model Micro SI Ambulatory Ecg Monitor	Advanced Medical Products, Inc.	1988	—
0 (this device)	K042799	QRS-Card Cardiology Suite	Pulse Biomedical, Inc.	2004	—
+1	K142352	CardiacLinx	Ross Medical Technology, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1995	1	0
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K042799, 1988–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 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? (5)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K930564	Holter for Windows	North East Monitoring, Inc.	1995	—
*	K012686	Caird Technology Holter 2000 Summary page 1 …edicate device(s) are the following: 1 Northeast Monitoring Inc. Hloter for Windows System (5 10(k) K(9305 64). 2. Caird Technology Hloter 2000 System. (5 10(k) K012686). 3. Advanced lBioSensor ABS Holter (formerly Micro SI Ambulatory ECG Monitor) System (510(k) K(881905). 4. Oxford…	Caird Technology	2001	—
*	K881905	Model Micro SI Ambulatory Ecg Monitor Summary page 1 …. 2. Caird Technology Hloter 2000 System. (5 10(k) K012686). 3. Advanced lBioSensor ABS Holter (formerly Micro SI Ambulatory ECG Monitor) System (510(k) K(881905). 4. Oxford Scientific Medilog Excel 2 System. (5 10(k) 1(002544). 5. Biomed Systems Inc. WinPV Holter System. (5 10(k) 1…	Advanced Medical Products, Inc.	1988	—
*	K002544	Medilog Excel 2 - Holter Management System Summary page 1 …3. Advanced lBioSensor ABS Holter (formerly Micro SI Ambulatory ECG Monitor) System (510(k) K(881905). 4. Oxford Scientific Medilog Excel 2 System. (5 10(k) 1(002544). 5. Biomed Systems Inc. WinPV Holter System. (5 10(k) 1(8841524). These predicate devices have the same performance specifi…	Oxford Instruments	2000	—
*	K884152	Century Color Trace Summary page 1 …Monitor) System (510(k) K(881905). 4. Oxford Scientific Medilog Excel 2 System. (5 10(k) 1(002544). 5. Biomed Systems Inc. WinPV Holter System. (5 10(k) 1(8841524). These predicate devices have the same performance specifications as the Cardiology Suite 4 .0 Tm Ambulatory ECG Analysis Syst…	Biomedical Systems, Inc.	1988	—

Also cleared against K930564: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142352	CardiacLinx	Ross Medical Technology, Inc.	2015	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?

None of the 5 ancestors has a recall.
Of its descendants, K142352 (Ross Medical Technology, Inc., 2015) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K930564.

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	—

What is it indicated for?

Read the full statement (167 words)

The QRS-Card Cardiology Suite 4.0TM Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.

The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042799 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042799: QRS-Card Cardiology Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042799

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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