510(k) · Cleared
Cleared3 Channel Digital Ambulatory Ecg Recorder Model Galix Gbi-3SM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galix Biomedical Instrumentation, Inc. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Jul 9, 2010 after a 296-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 9, 2010
- Review
- 296 days
- Class
- Class II
- Product code
- MLO
- 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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The primary use of ambulatory monitoring are listed below. 1- Evaluation of suspected of known cardiac rhythm disorders. 2 - Evaluation of symptoms suggestive of an arrhythmia disorder. 3 - 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. 4 - Patients who have suspected pacemaker malfunction may also require long term monitoring to document an…
Read the full statement (174 words)
The primary use of ambulatory monitoring are listed below.
1- Evaluation of suspected of known cardiac rhythm disorders.
2 - Evaluation of symptoms suggestive of an arrhythmia disorder.
3 - 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.
4 - Patients who have suspected pacemaker malfunction may also require long term monitoring to document an intermittent episode of failure to capture or failures to sense.
5 - Evaluation of chest pain.
6 - Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment.
7 - The Galix GBI-3SM Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Bolter Recorder. However the unit has the ability to record Very High Resolution ECG, at a sampling rate of 1000 samples per second.
The ECG data stored is then analyzed with the Late Potential Software.
Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092853: 3 Channel Digital Ambulatory Ecg Recorder Model Galix Gbi-3SM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092853
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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