510(k) · Cleared
ClearedMoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infobionic, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jul 29, 2025 as substantially equivalent to K230265 (Infobionic, Inc., 2023) and 1 other predicate after a 172-day review. Its family tree reaches back 11 generations to 1988.
- Decided
- Jul 29, 2025
- Review
- 172 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K882803 (1988). 46 ancestors in all, the oldest K843503 (1984). No later device cites it as a predicate yet.
- Root · 11 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 7 generations between
- 3 generations backK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
- 2 generations backK160064 MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2016
- 1 generation backK230265 MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
- This deviceK250356 MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System…Infobionic, Inc. · 2025
Show all 11 generations
- Root · 11 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 10 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 9 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 8 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 7 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 6 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 5 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 4 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 3 generations backK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
- 2 generations backK160064 MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2016
- 1 generation backK230265 MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
- This deviceK250356 MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System…Infobionic, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −10 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −9 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −8 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −7 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −6 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −5 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −4 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| −3 | K100155 | Truvue Wireless Ambulatory Ecg Monitoring System | Biomedical Systems Corp. | 2010 | — |
| −2 | K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2016 | — |
| −1 | K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2023 | — |
| 0 (this device) | K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 2 | 0 |
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemSummary page 5…Arrhythmia Detection 510(k) Submitter / Holder InfoBionic, Inc. Braemar Manufacturing, LLC 510(k) Number K230265 K153473 Regulation Number 21 CFR Part 870.1025 21 CFR Part 870.10… | 2023 |
| * | K153473 | Braemar Telemetry Patch SystemSummary page 5…510(k) Submitter / Holder InfoBionic, Inc. Braemar Manufacturing, LLC 510(k) Number K230265 K153473 Regulation Number 21 CFR Part 870.1025 21 CFR Part 870.1025 Classification Panel Car… | 2016 |
| † | K152491 | MoMe Software Platform | 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 37 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 46 ancestors have a recall of any class.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
MoMe ARC® is indicated for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which…
Read the full statement (209 words)
MoMe ARC® is indicated for:
1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports.
MoMe ARC® is contraindicated for:
1. MoMe ARC® is contraindicated for those patients requiring attended, in hospital monitoring for life threatening arrhythmias.
2. MoMe ARC® is not intended for use on infants weighing less than 10kg (22lbs.). Clinical judgement is necessary to determine if the MoMe ARC® is appropriate for specific pediatric patients.
3. The patch configuration of the MoMe ARC® is contraindicated for monitoring QT intervals for patients taking Class III antiarrhythmic drugs.
Note: MoMe ARC® does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250356: MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250356
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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