510(k) · Cleared
ClearedCV3000 Holter Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vales & Hills Biomedical Tech., Ltd. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Nov 26, 2013 as substantially equivalent to K101273 (Contec Medical System Co., Ltd., 2011) after a 154-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Nov 26, 2013
- Review
- 154 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K911097 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK911097 PR4Mortara Instrument, Inc. · 1991
- 3 generations backK021373 H12+Holter RecorderMortara Instrument, Inc. · 2002
- 2 generations backK051730 Matrix Holter System, Model M12Global Instrumentation, LLC · 2005
- 1 generation backK101273 Dynamic Ecg System Model TLC5000Contec Medical System Co., Ltd. · 2011
- This deviceK131897 CV3000 Holter Analysis SystemVales & Hills Biomedical Tech., Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| −3 | K021373 | H12+Holter Recorder | Mortara Instrument, Inc. | 2002 | — |
| −2 | K051730 | Matrix Holter System, Model M12 | Global Instrumentation, LLC | 2005 | — |
| −1 | K101273 | Dynamic Ecg System Model TLC5000 | Contec Medical System Co., Ltd. | 2011 | — |
| 0 (this device) | K131897 | CV3000 Holter Analysis System | Vales & Hills Biomedical Tech., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 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 |
|---|---|---|---|
| * | K101273 | Dynamic Ecg System Model TLC5000Summary page 2…rst and then download to PC for analysis, reviewing and printing by a trained physician in health facilities. 5. Predicate Device Identification 510(k) Number: K 10 1273 Product Name: Dynamic ECG Systems, TLC5000 Manufacturer: CONTEC Medical System Co., Ltd 6. Device Description The C… | 2011 |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a 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. 2013, 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 proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131897 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131897: CV3000 Holter Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131897
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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