510(k) · Cleared
ClearedTruvue Wireless Ambulatory Ecg Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Systems Corp. · DSI Detector And Alarm, Arrhythmia
Cleared on Apr 20, 2010 as substantially equivalent to K081257 (Card Guard Scientific Survival, Ltd., 2008) and 2 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1988. 6 later devices descend from it.
- Decided
- Apr 20, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K882803 (1988). 38 ancestors in all, the oldest K843503 (1984). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 7 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 6 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 5 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 4 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 3 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 2 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 1 generation backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- This deviceK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
- Descendant · cites it directly · 3 of its ownK160064 MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK230265 MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK250356 MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System…Infobionic, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK231276 SmartCardia 7L PlatformSmartcardia SA · 2023
- Descendant · cites it directly · 0 of its ownK131000 V-Patch SystemIntelesens Limited · 2014
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2016 · cites it directly3descendants
- K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023 · 2 generations on1descendant
- K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025 · 3 generations on0descendants
- K231276SmartCardia 7L PlatformSmartcardia SA · 2023 · 2 generations on0descendants
- K131000V-Patch SystemIntelesens Limited · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −7 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −6 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −5 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −4 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −3 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −2 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −1 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| 0 (this device) | K100155 | Truvue Wireless Ambulatory Ecg Monitoring System | Biomedical Systems Corp. | 2010 | — |
| +1 | K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2016 | — |
| +2 | K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2023 | — |
| +3 | K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | 2025 | — |
| +2 | K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023 | — |
| +1 | K131000 | V-Patch System | Intelesens Limited | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 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 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K081257 | CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorSummary page 1…uivalence: The TruVue"" System is substantially equivalent to following previously cleared devices: 1) CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmiia DetectorK081257 2) NUVANT, Mobile Cardiac Telemetry System, K091971 3) Medicalgorithmics Real-TimeECGGMonitor and Arrhythmia Detector, K0… | 2008 |
| * | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemSummary page 1…ent to following previously cleared devices: 1) CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmiia DetectorK081257 2) NUVANT, Mobile Cardiac Telemetry System, K091971 3) Medicalgorithmics Real-TimeECGGMonitor and Arrhythmia Detector, K090037 TruVueTrm CG-61 08… | 2009 |
| * | K090037 | Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgSummary page 1…CG Monitor and Arrhythmiia DetectorK081257 2) NUVANT, Mobile Cardiac Telemetry System, K091971 3) Medicalgorithmics Real-TimeECGGMonitor and Arrhythmia Detector, K090037 TruVueTrm CG-61 08 PocketECG NV T SE… | 2009 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K160064 (Infobionic, Inc., 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K081257.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
1. The TruVueTM System is intended for use by patients who experience transient events 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 lightheadtedness; b) syncope of unknown etiology in…
Read the full statement (125 words)
1. The TruVueTM System is intended for use by patients who experience transient events 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 lightheadtedness; 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 who are indicated for outpatient arrhythmia monitoring.
5. EGG data recorded by the device can be analyzed by other processing systems, such as the EMS Century Holter system to provide Halter style reports
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100155: Truvue Wireless Ambulatory Ecg Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100155
Report an extraction error
Are you the manufacturer?
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