510(k) · Cleared
ClearedNuvant, Mobilc Cardiac Telemetry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corventis, Inc. · QYX Outpatient Cardiac Telemetry
Cleared on Mar 7, 2012 as substantially equivalent to K111917 (Corventis, Inc., 2011) after a 112-day review. Its family tree reaches back 9 generations to 1988. 24 later devices descend from it.
- Decided
- Mar 7, 2012
- Review
- 112 days
- Class
- Class II
- Product code
- QYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K882803 (1988). 23 ancestors in all. 24 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 5 generations between
- 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 1 generation backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- This deviceK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- Descendant · cites it directly · 23 of its ownK133701 Nuvant MCT SystemCorventis, Inc. · 2014
- Descendant · 2 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 12 of its ownK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
- Descendant · 4 generations on · 6 of its ownK210822 DeepRhythmAIMedicalgorithmics S.A. · 2022
- Descendant · 4 generations on · 4 of its ownK190593 Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2019
Show all 9 generations
- Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 8 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 7 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 6 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 5 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 4 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 1 generation backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- This deviceK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K133701Nuvant MCT SystemCorventis, Inc. · 2014 · cites it directly23descendants
- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 2 generations on18descendants
- K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018 · 3 generations on12descendants
- K210822DeepRhythmAIMedicalgorithmics S.A. · 2022 · 4 generations on6descendants
- K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −8 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −7 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −6 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −5 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −4 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −3 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −2 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| −1 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| 0 (this device) | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
| +1 | K133701 | Nuvant MCT System | Corventis, Inc. | 2014 | — |
| +2 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
| +3 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | — |
| +4 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022 | — |
| +4 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 QYX? 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 QYX device
- #1 K250793 RhythmStar System (SL)score 14.8 · 13 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 |
|---|---|---|---|
| * | K111917 | Nuvant, Mobile Cardiac TelemetrySummary page 5…duct Code MHX) Class ll, Special Controls Special 510(k) November 15, 2011 NUVANT Mobile Cardiac Telemetry System, Corventis, Inc. cleared by FDA under 510(k) number K111917; 21 CFR 870.1025, DSI “Arrhythmia Detector and Alarm”, and 21 CFR 870.1025, MHX “Patient Physiological Monitor (with arrhythmia… | 2011 |
What descends from it? (24)
See all 242 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 24 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K133701 (Corventis, Inc., 2014) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K111917.
How does its category compare?
All QYX devicesQYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · QYX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QYX
244in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QYX
No recall names QYX since 2007.
Adverse event reports per year · QYX
107in 2025
MAUDE reports naming product code QYX, 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 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 169 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 74 |
| 2024 | 3 | 244 | 0 | 400 |
| 2025 | 1 | — | 0 | 107 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.
The NUVANT system model monitors, derives and displays:
* ECG
* Heart Rate
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/K113372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113372: Nuvant, Mobilc Cardiac Telemetry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113372
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