510(k) · Cleared

Cleared

Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System

K090696510(k) SpecialCleared Jun 19, 200995-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Corventis, Inc. · QYX Outpatient Cardiac Telemetry

Cleared on Jun 19, 2009 as substantially equivalent to K083287 (Corventis, Inc., 2009) and 3 other predicates after a 95-day review. Its family tree reaches back 6 generations to 1988. 40 later devices descend from it.

Decided: Jun 19, 2009
Review: 95 days
Class: Class II
Product code: QYX
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K882803 (1988). 17 ancestors in all. 40 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 6 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
5 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
4 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
3 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
2 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
1 generation backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
This deviceK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
Descendant · cites it directly · 38 of its ownK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
Descendant · 2 generations on · 30 of its ownK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
Descendant · 3 generations on · 24 of its ownK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
Descendant · 4 generations on · 23 of its ownK133701 Nuvant MCT SystemCorventis, Inc. · 2014
Descendant · 5 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2009high 5 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 40 · See all

K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) SystemCorventis, Inc. · 2009 · cites it directly38descendants
K111917Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011 · 2 generations on30descendants
K113372Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012 · 3 generations on24descendants
K133701Nuvant MCT SystemCorventis, Inc. · 2014 · 4 generations on23descendants
K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 5 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K882803	ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST	Advanced Cardiovascular Systems, Inc.	1988	—
−5	K012241	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001	Cardionet, Inc.	2002	—
−4	K052240	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002	Cardionet, Inc.	2005	—
−3	K063222	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004	Cardionet, Inc.	2006	—
−2	K072558	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005	Cardionet, Inc.	2007	—
−1	K083287	Avivo Mobile Patient Management System	Corventis, Inc.	2009	—
0 (this device)	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	—
+2	K111917	Nuvant, Mobile Cardiac Telemetry	Corventis, Inc.	2011	—
+3	K113372	Nuvant, Mobilc Cardiac Telemetry	Corventis, Inc.	2012	—
+4	K133701	Nuvant MCT System	Corventis, Inc.	2014	—
+5	K163512	Zio AT ECG Monitoring System	iRhythm Technologies, Inc.	2017	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	3	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2004	2	0
2005	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2011	2	0
2012	2	0
2014	2	0
2015	1	0
2016	2	0
2017	3	0
2018	2	0
2019	3	0
2021	1	0
2022	2	0
2023	4	0
2024	5	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K090696, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K083287	Avivo Mobile Patient Management System Summary page 5 …pecial Controls Special 510(k): Device Modification Predicate Devices: I. AVIVO Mobile Patient Management System, Corventis, Inc., cleared by FDA under 510(k) number K083287; 21 CFR 870.1025, DSI “Arrhythmia Detector and Alarm”, and 21 CFR 870.1025, MHX “Patient Physiological Monitor (with arrhythmia d…	Corventis, Inc.	2009	—
*	K042022	E-Tac EX-1000 Electrocardiographic Event Recorder Summary page 5 …025, MHX “Patient Physiological Monitor (with arrhythmia detection)” E-Tac EX-1000 electrocardiographic Event Recorder, Datrix, Inc., cleared by FDA under 510(k) number K042022; 21 CFR 870.2920, DXH “Telephone electrocardiographic transmitter and receiver” SIM Confirm Model DM2100 Implantable Cardiac Mon…	Datrix, Inc. Dba of Jon Barron, Inc.	2004	—
*	K081365	SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient Activator Summary page 5 …tter and receiver” SIM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM 2100A Patient Activator, St. Jude Medical, CRMD, cleared by FDA under 510(k) number K081365; 21 CFR 870.2800, MXC “Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)” Cardionet Ambulatory ECG Monitor wi…	St Jude Medical	2008	1
*	K063222	Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 Summary page 5 …Cardiac, (Without Arrhythmia Detection)” Cardionet Ambulatory ECG Monitor with Arrhythmia Detections, Model CN1004, Cardionet, Inc., cleared by FDA under 510(k) number K063222; CFR 870.1025, DSI “Arrhythmia Detector and Alarm” Page 1 of 4 510(k) Summary of Safety & Effectiveness Date: Ju…	Cardionet, Inc.	2006	—

Also cleared against K083287: 5 other devices →

What descends from it? (40)

See all 40

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091971	Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System	Corventis, Inc.	2009	38
K113187	Avivo Mobile Patient Management	Corventis, Inc.	2012	5
K102111	Medical Magnetic Tape Recorder	Wpr Medical AS	2010	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 21 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
1 of the 17 ancestors has a recall of any class.
Of its descendants, K091971 (Corventis, Inc., 2009) has gone furthest, with 38 descendants of its own.
5 other devices also cite its predicate K083287.

How does its category compare?

All QYX devices

QYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · QYX

1in 2025

2007high 3 (2017) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QYX

244in 2024

2007high 244 (2024) · low 169 (2017)2026

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

2007high 400 (2024) · low 0 (2007)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	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	1	—	0
2010	1	—	0
2011	2	—	0
2012	1	—	0
2013	0	—	0
2014	2	—	0
2015	0	—	0
2016	1	—	0
2017	3	169	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	74
2024	3	244	400
2025	1	—	107
2026	1	—	—

What is it indicated for?

The NUVANT Cardiac Event Monitor (CEM) System and the NUVANT Mobile Cardiac Telemetry (MCT) System are intended to continuously measure, record, and periodically transmit physiological data, The Systems are indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Both NUVANT system models monitor, derive and display:

ECG

Heart rate

The Systems may also monitor, derive and display:

Activity

Posture

Respiration rate (including RR Variability)

Body fluid status

Heart rate variability

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/K090696 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090696

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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