510(k) · Cleared
ClearedDynamic Ecg System Model TLC5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contec Medical System Co., Ltd. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Sep 30, 2011 as substantially equivalent to K051730 (Global Instrumentation, LLC, 2005) after a 512-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- Sep 30, 2011
- Review
- 512 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911097 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK911097 PR4Mortara Instrument, Inc. · 1991
- 2 generations backK021373 H12+Holter RecorderMortara Instrument, Inc. · 2002
- 1 generation backK051730 Matrix Holter System, Model M12Global Instrumentation, LLC · 2005
- This deviceK101273 Dynamic Ecg System Model TLC5000Contec Medical System Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK131897 CV3000 Holter Analysis SystemVales & Hills Biomedical Tech., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131897CV3000 Holter Analysis SystemVales & Hills Biomedical Tech., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| −2 | K021373 | H12+Holter Recorder | Mortara Instrument, Inc. | 2002 | — |
| −1 | K051730 | Matrix Holter System, Model M12 | Global Instrumentation, LLC | 2005 | — |
| 0 (this device) | K101273 | Dynamic Ecg System Model TLC5000 | Contec Medical System Co., Ltd. | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K051730 | Matrix Holter System, Model M12Summary page 1…re, safety and effectiveness were demonstrated substantially equivalent (SE) to the predicate device. Predicate Device Matrix Holler System, K05 1730 SE Conclusion The proposed device, Dynamic ECG System, TLC5000 is substantially equivalent (SE) to the predicate… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131897 | CV3000 Holter Analysis System | 2013 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131897 (Vales & Hills Biomedical Tech., Ltd., 2013) has gone furthest, with 0 descendants of its own.
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. 2011, 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?
Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K101273 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101273: Dynamic Ecg System Model TLC5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101273
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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