510(k) · Cleared
ClearedFaros Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bittium Biosignals, Ltd. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Nov 8, 2018 as substantially equivalent to K140847 (Labtech Kft., 2014) after a 101-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Nov 8, 2018
- Review
- 101 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K930806 (1994). 28 ancestors in all, the oldest K871344 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK930806 Zymed Holter Scanner Model 2010Agilent Technologies · 1994
- 5 generations backK955015 Zymed Holter Scanner Model 2010Zymed Medical Instrumentation · 1996
- 4 generations backK990170 Holter 2000Zymed Medical Instrumentation · 1999
- 3 generations backK010949 2010 Plus Holter for WindowsAgilent Technologies · 2001
- 2 generations backK042108 Vista PlusNovacor · 2005
- 1 generation backK140847 Cardiospy Ecg Holter SystemsLabtech Kft. · 2014
- This deviceK182030 Faros MobileBittium Biosignals, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930806 | Zymed Holter Scanner Model 2010 | Agilent Technologies | 1994 | — |
| −5 | K955015 | Zymed Holter Scanner Model 2010 | Zymed Medical Instrumentation | 1996 | — |
| −4 | K990170 | Holter 2000 | Zymed Medical Instrumentation | 1999 | — |
| −3 | K010949 | 2010 Plus Holter for Windows | Agilent Technologies | 2001 | — |
| −2 | K042108 | Vista Plus | Novacor | 2005 | — |
| −1 | K140847 | Cardiospy Ecg Holter Systems | Labtech Kft. | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K140847 | Cardiospy Ecg Holter SystemsSummary page 5…K182030 Abbreviated 510(k) Premarket Submission 4. Substantial equivalence, predicate device K140847, CARDIO SPY ECG Holter Systems by LABTECH KFT. Reference device: technology, design functionality K143032, eMotion Faros ECG… | 2014 |
| † | K143032 | eMotion Faros ECG Mobile | 2015 |
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 24 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 28 ancestors has a recall of any class.
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. 2018, 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 Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments. Faros Mobile provides the detection and reporting features appropriate for the indications below * Evaluation of patients with symptoms related to rhythm disturbances or symptoms…
Read the full statement (161 words)
The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis.
Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments.
Faros Mobile provides the detection and reporting features appropriate for the indications below
* Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias.
* Evaluation of patients for ST segment changes
* Evaluation patients with pacemaker
* Evaluating patient rest and stress ECG
* Reporting heart rate variability analysis
» Wireless transmission of patient ECG data and arrhythmia events for further analysis.
Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements.
Faros Mobile is contraindicated for
* Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias
* Pediatric patients weighting less than 10 kg
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/K182030 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182030: Faros Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182030
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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