510(k) · Cleared
ClearedCardiospy Ecg Holter Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Labtech Kft. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Dec 5, 2014 as substantially equivalent to K042108 (Novacor, 2005) and 3 other predicates after a 246-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Dec 5, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K930806 (1994). 27 ancestors in all, the oldest K871344 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 4 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 3 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 2 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 1 generation backK042108 Vista PlusNovacor · 2005
- This deviceK140847 Cardiospy Ecg Holter SystemsLabtech Kft. · 2014
- Descendant · cites it directly · 0 of its ownK182030 Faros MobileBittium Biosignals, Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K182030Faros MobileBittium Biosignals, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −4 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −3 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −2 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −1 | K042108 | Vista Plus | Novacor | 2005 | — |
| 0 (this device) | K140847 | Cardiospy Ecg Holter Systems | Labtech Kft. | 2014 | — |
| +1 | K182030 | Faros Mobile | Bittium Biosignals, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042108 | Vista PlusSummary page 5…evice models: EC-1H, EC-2H, EC-3H, EC-12H Predicate devices 1. Vista Plus – Novacor France - K042108 2. Spiderview ELA MEDICAL Inc. - K032466 3.… | 2005 |
| * | K032466 | SpiderviewSummary page 5…ce - K042108 2. Spiderview ELA MEDICAL Inc. - K032466 3. Cardio ID+(RZI153±) - ScottCare (ROZINN ELECTRONICS Inc.) - K022540 4.… | 2003 |
| * | K022540 | Cardio ID+(RZ153+)Summary page 5…c. - K032466 3. Cardio ID+(RZI153±) - ScottCare (ROZINN ELECTRONICS Inc.) - K022540 4. Digitrak Plus - BRAEMAR CORP - K993617 Device Des… | 2002 |
| * | K993617 | Digitrakplus Holter RecorderSummary page 5…ttCare (ROZINN ELECTRONICS Inc.) - K022540 4. Digitrak Plus - BRAEMAR CORP - K993617 Device Description The battery powered Cardiospy ECG Holter System provides 1, 2, 3 and 12 channel recordings,… | 1999 |
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 |
|---|---|---|---|
| K182030 | Faros Mobile | 2018 | 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 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K182030 (Bittium Biosignals, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K042108.
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. 2014, 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 Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis. The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years)…
Read the full statement (143 words)
The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis.
The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years):
* Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia.
* Evaluation of patients for ST segment changes
* Evaluation of patients with pacemakers
Reporting of time domain heart rate variability
« Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after MI. or cardiac surgery.)
« Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients
* Clinical and epidemiological research studies
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/K140847 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140847: Cardiospy Ecg Holter Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140847
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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