510(k) · Cleared
ClearedCentury Series Holter Scanner System, Models C3000, C2000 and C1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Systems Corp. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Jun 30, 2003 as substantially equivalent to K884152 (Biomedical Systems, Inc., 1988) after a 186-day review. Its family tree reaches back 1 generation to 1988. 9 later devices descend from it.
- Decided
- Jun 30, 2003
- Review
- 186 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884152 (1988). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK884152 Century Color TraceBiomedical Systems, Inc. · 1988
- This deviceK024323 Century Series Holter Scanner System, Models C3000, C2000 and C1000Biomedical Systems Corp. · 2003
- Descendant · cites it directly · 8 of its ownK053263 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- Descendant · 2 generations on · 7 of its ownK093288 Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK153473 Braemar Telemetry Patch SystemBraemar Manufacturing, LLC · 2016
- Descendant · 3 generations on · 1 of its ownK133753 Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K053263Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003Cardionet, Inc. · 2006 · cites it directly8descendants
- K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010 · 2 generations on7descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · 3 generations on2descendants
- K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC · 2016 · 3 generations on1descendant
- K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884152 | Century Color Trace | Biomedical Systems, Inc. | 1988 | — |
| 0 (this device) | K024323 | Century Series Holter Scanner System, Models C3000, C2000 and C1000 | Biomedical Systems Corp. | 2003 | — |
| +1 | K053263 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003 | Cardionet, Inc. | 2006 | — |
| +2 | K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection | Cardionet, Inc. | 2010 | — |
| +3 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +3 | K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | 2016 | — |
| +3 | K133753 | Mome Ecg Continuous Detection and Arrhythmia Detector | Infobionic, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
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 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? (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 | Decided |
|---|---|---|---|
| * | K884152 | Century Color TraceSummary page 1…cation name Medical Magnetic Tape Recorder Product classification 74 MLO, 21 CFR 870.2800, Class I1 Predicate Device Century Color Trace (K884152, Biomedical Systems) Device Description The Century Series Holter Scanner System, Model… | 1988 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053263 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1003 | 2006 | 8 |
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?
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.
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 Century Series Holter Scanner System, Model C3000/C2000/C1000 is intended for the replay and analysis of ECG data pre-recorded on compatible cassette tape or digital Holter recorders and is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms…
Read the full statement (153 words)
The Century Series Holter Scanner System, Model C3000/C2000/C1000 is intended for the replay and analysis of ECG data pre-recorded on compatible cassette tape or digital Holter recorders and is indicated for:
Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias.
To assess risk for future cardiac events in patients without symptoms from arrhythmia who have bee diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction.
Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation.
ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
Patient population: human beings without restrictions of age, sex, or race requiring analysis of 24 hour ambulatory ECG recordings as determined by a medical practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024323 · printed Nov 4, 2026
Cite this page
510(k) Report. “K024323: Century Series Holter Scanner System, Models C3000, C2000 and C1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K024323
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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