510(k) Report

510(k) · Cleared

Cleared

3 Channel Digital Ambulatory Ecg Recorder

K971670510(k) TraditionalCleared Jan 29, 1998268-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

Galix Biomedical Instrumentation, Inc. · DSH Recorder, Magnetic Tape, Medical

Cleared on Jan 29, 1998 after a 268-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jan 29, 1998
Review
268 days
Class
Class II
Product code
DSH
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K971670Source: FDA 510(k) database · 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DSH? 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 DSH device

  1. #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All DSH devices

DSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSH

4in 2025

2007: 12008: 12009: 32010: 22011: 62012: 22013: 22014: 12015: 22016: 22017: 32018: 32019: 32020: 42021: 42022: 42023: 62024: 22025: 42026 (partial year): 2
2007high 6 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSH

205in 2025

2009: 84 days median2011: 64 days median2017: 91 days median2018: 269 days median2019: 30 days median2020: 122 days median2021: 263 days median2022: 427 days median2023: 198 days median2025: 205 days median
2007high 427 (2022) · low 30 (2019)2026

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

Recalls per year · DSH

No recall names DSH since 2007.

Adverse event reports per year · DSH

213in 2025

2009: 12010: 82011: 32012: 12013: 22014: 32015: 82016: 62017: 312018: 302019: 762020: 912021: 1132022: 462023: 652024: 882025: 213
2007high 213 (2025) · low 0 (2007)2025

MAUDE reports naming product code DSH, 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
20071—00
20081—00
200938401
20102—08
201166403
20122—01
20132—02
20141—03
20152—08
20162—06
2017391031
20183269030
2019330076
20204122091
202142630113
20224427046
20236198065
20242—088
202542050213
20262—0—

What is it indicated for?

Electrocardiographic recording to document a patient’s arrhythmia has had widespread application as a non invasive tool in cardiology. A patient’s arrhythmia may be documented by a simple electrocardiogram; however the use of techniques with longer monitoring periods, usually for 24 hours or more (Holter monitoring), increases the likelihood of documenting the arrhythmia. Since the original description by Dr Norman Holter in the 1950 s, Holter monitoring…

Read the full statement (449 words)

Electrocardiographic recording to document a patient’s arrhythmia has had widespread application as a non invasive tool in cardiology. A patient’s arrhythmia may be documented by a simple electrocardiogram; however the use of techniques with longer monitoring periods, usually for 24 hours or more (Holter monitoring), increases the likelihood of documenting the arrhythmia. Since the original description by Dr Norman Holter in the 1950 s, Holter monitoring or continuous ambulatory electrocardiographic monitoring has been a useful technique for patients with cardiac arrhythmias.

Indications for Holter monitoring are listed in Table I. The primary use of ambulatory monitoring is for the evaluation of cases of suspected cardiac rhythm disturbances. Since these arrhythmias can be episodic, detection of complex ventricular arrhythmias will vary, depending of the duration of the recording.

A 24 - hour Holter recording permits the recording of cardiac rhythm during both sleep and awake states. Thus the variation of arrhythmias during waking hours and during physical and mental stress can be demonstrated.

TABLE I: Indications for Holter monitoring

1 - Evaluation of suspected or known cardiac rhythm disorders.

2 - Evaluation of symptoms suggestive of an arrhythmia disorder.

3 - Evaluation of clinical syndromes in which arrhythmias may increase the risk of sudden death.

4 - Evaluation of pacemaker function.

5 - Evaluation of chest pam

Holter monitors are used in a serial fashion to judge the efficacy of antiarrthythmic drug treatment.

Holter monitors are frequently used as part of diagnostic studies to determine whether a new cardioactive drug has either antiarrhythmic or proarrhythmic effects. Because of spontaneous variability of a patient's arrhythmia these studies are often limited and should be viewed with caution.

Studies that have used longer monitoring periods may be more accurate.

Holter monitors may also be used for screening patients with symptoms suggestive of sinus node or AV node conduction problems.

Holter monitoring can be useful in correlating episodes of chest pain with diagnostic ST segment abnormalities.

Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death.

Such situations-include: theperiod-after myocardfal -infarction, Congestive heart failure and dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, and the congenital prolonged QT syndrome.

Holter recordings may also be useful in screening for arrhythmias in patients with the mitral valve prolapse syndrome and in those recovering from coronary artery bypass surgery.

Holter monitoring can aiso be used to screen patients with symptomatic or asymptomatic Wolff - Parkinson - White syndrome.

Patients who have suspected pacemaker malfunction may aiso require long-term monitoring to document an intermittent episode of failure to capture or failure to sense. These abnormalities and oversensing problems may be easily documented during ambulatory monitoring.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K971670: 3 Channel Digital Ambulatory Ecg Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971670

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026