510(k) · Cleared
ClearedMatrix Holter System, Model M12
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global Instrumentation, LLC · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Sep 26, 2005 as substantially equivalent to K021373 (Mortara Instrument, Inc., 2002) and 2 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 26, 2005
- Review
- 91 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K911097 (1991). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK911097 PR4Mortara Instrument, Inc. · 1991
- 1 generation backK021373 H12+Holter RecorderMortara Instrument, Inc. · 2002
- This deviceK051730 Matrix Holter System, Model M12Global Instrumentation, LLC · 2005
- Descendant · cites it directly · 1 of its ownK101273 Dynamic Ecg System Model TLC5000Contec Medical System Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK131897 CV3000 Holter Analysis SystemVales & Hills Biomedical Tech., Ltd. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| −1 | K021373 | H12+Holter Recorder | Mortara Instrument, Inc. | 2002 | — |
| 0 (this device) | K051730 | Matrix Holter System, Model M12 | Global Instrumentation, LLC | 2005 | — |
| +1 | K101273 | Dynamic Ecg System Model TLC5000 | Contec Medical System Co., Ltd. | 2011 | — |
| +2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K040417 | FDA’s K040417 is Pillar Palatal Implant System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K021373 | H12+Holter RecorderSummary page 1…are: Mortara H-Scribe Holter Analysis System (KO040 17) Mortara H 12± Holter Recorder (K02 1373) Burdick PC H-olter Scanning System (K945985) Burdick Altai… | 2002 |
| * | K945985 | PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400Summary page 1…lysis System (KO040 17) Mortara H 12± Holter Recorder (K02 1373) Burdick PC H-olter Scanning System (K945985) Burdick Altair-Disc Recorder (K942565)… | 1995 |
| * | K942565 | Altair-Disc RecorderSummary page 1…lter Recorder (K02 1373) Burdick PC H-olter Scanning System (K945985) Burdick Altair-Disc Recorder (K942565) Page 38 of41 Confidential Material… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101273 | Dynamic Ecg System Model TLC5000 | 2011 | 1 |
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 14 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K101273 (Contec Medical System Co., Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K021373.
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 M12 Matrix Holter System is intended for use by trained operators in health facilities. The subject Device will provide the following diagnostic functions:
• Acquiring, viewing, storing and printing Ambulatory ECG waveforms for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
* Using optional algorithms to generate measurements, data presentations, and graphical presentations on an advisory basis for the subject patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG tracings, and other clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051730 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051730: Matrix Holter System, Model M12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051730
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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