510(k) · Cleared

Cleared

Digitrakplus Holter Recorder

K993617510(k) SpecialCleared Nov 24, 199929-day reviewClass II21 CFR 870.2800

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

Braemar Corp. · MWJ Electrocardiograph, Ambulatory (Without Analysis)

Cleared on Nov 24, 1999 as substantially equivalent to K950944 (Biosensor Corp., 1996) after a 29-day review. Its family tree reaches back 1 generation to 1996. 62 later devices descend from it.

Decided: Nov 24, 1999
Review: 29 days
Class: Class II
Product code: MWJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950944 (1996). 62 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK950944 Ambulatory (Holter) Recording SystemBiosensor Corp. · 1996
This deviceK993617 Digitrakplus Holter RecorderBraemar Corp. · 1999
Descendant · cites it directly · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
Descendant · cites it directly · 46 of its ownK042108 Vista PlusNovacor · 2005
Descendant · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
Descendant · 2 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
Descendant · 3 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2003high 6 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 62 · See all

K032466SpiderviewEla Medical, Inc. · 2003 · cites it directly56descendants
K042108Vista PlusNovacor · 2005 · cites it directly46descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 2 generations on30descendants
K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 3 generations on28descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950944	Ambulatory (Holter) Recording System	Biosensor Corp.	1996	—
0 (this device)	K993617	Digitrakplus Holter Recorder	Braemar Corp.	1999	—
+1	K032466	Spiderview	Ela Medical, Inc.	2003	—
+1	K042108	Vista Plus	Novacor	2005	—
+2	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—
+2	K071655	Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…	Medtronic, Inc.	2007	—
+3	K082475	Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…	Medtronic, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2007	3	0
2008	1	0
2010	2	0
2011	3	0
2012	2	0
2013	1	0
2014	4	0
2015	4	0
2016	5	0
2017	6	0
2018	2	0
2019	4	0
2020	4	0
2021	4	0
2022	2	0
2023	6	0
2024	1	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K993617, 1996–2026Source: 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 MWJ? 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 MWJ device

#1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K950944	Ambulatory (Holter) Recording System Summary page 1 oV 2.4 1999 i 40 % (71 Section 2: 510(k) SUMMARY e Substantially Equivalent (SE) To: Biosensor Model #1005 510(k) # K950944 Modification Background The essence of this modification is a change of the digital Holter recorder hardware to a smaller confi…	Biosensor Corp.	1996	—

Also cleared against K950944: 3 other devices →

What descends from it? (62)

See all 62

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

Number	Device	Applicant	Decided	Descendants
K032466	Spiderview	Ela Medical, Inc.	2003	56
K042108	Vista Plus	Novacor	2005	46
K043010	Holter Recorder H3+	Mortara Instrument, Inc.	2005	4
K102723	Model 950-12L Holter Recorder Without Analysis	Memtec Corp.	2010	3
K071085	E3-80 Portable Ecg Recorder & Analyzer	Micro-Star International Co., Ltd.	2007	3
K140847	Cardiospy Ecg Holter Systems	Labtech Kft.	2014	1
K112573	Ezsleep Sleep Quality Recorder	Platinum Team Co., Ltd.	2012	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?

Its one ancestor has no recall.
Of its descendants, K032466 (Ela Medical, Inc., 2003) has gone furthest, with 56 descendants of its own.
3 other devices also cite its predicate K950944.

How does its category compare?

All MWJ devices

MWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWJ

2in 2024

2007high 5 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWJ

337in 2022

2007high 337 (2022) · low 90 (2010)2026

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

Recalls per year · MWJ

2in 2024

2007high 2 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MWJ

8in 2025

2007high 12 (2020) · low 0 (2007)2025

MAUDE reports naming product code MWJ, 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	5	142	0	0
2008	1	—	0	0
2009	2	—	0	5
2010	3	90	0	0
2011	3	206	0	0
2012	1	—	0	2
2013	3	241	0	4
2014	2	—	0	1
2015	0	—	0	1
2016	2	—	0	1
2017	0	—	0	2
2018	1	—	0	1
2019	0	—	0	4
2020	0	—	0	12
2021	1	—	0	3
2022	4	337	0	6
2023	0	—	0	5
2024	2	—	2	3
2025	0	—	0	8
2026	5	270	0	—

What is it indicated for?

Read the full statement (211 words)

The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently, the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.

Ambulatory (Holter) ECG intended use:

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after ML or cardiac surgery.)

5. Clinical and epidemiological research studies.

6. Evaluation of patients with pacemakers

7. Reporting of time and frequency domain heart rate variability

8. Reporting of QT Interval

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

https://510kreport.com/device/K993617 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993617: Digitrakplus Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993617

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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