510(k) · Cleared
Cleared3 Channel Digital Ambulatory Ecg Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
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 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
- #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 devicesDSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSH
205in 2025
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
MAUDE reports naming product code DSH, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 3 | 84 | 0 | 1 |
| 2010 | 2 | — | 0 | 8 |
| 2011 | 6 | 64 | 0 | 3 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 3 | 91 | 0 | 31 |
| 2018 | 3 | 269 | 0 | 30 |
| 2019 | 3 | 30 | 0 | 76 |
| 2020 | 4 | 122 | 0 | 91 |
| 2021 | 4 | 263 | 0 | 113 |
| 2022 | 4 | 427 | 0 | 46 |
| 2023 | 6 | 198 | 0 | 65 |
| 2024 | 2 | — | 0 | 88 |
| 2025 | 4 | 205 | 0 | 213 |
| 2026 | 2 | — | 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.
https://510kreport.com/device/K971670 · printed Nov 4, 2026
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