510(k) · Cleared
ClearedNowcardio System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contex International Technologies (Canada), Inc. · QYX Outpatient Cardiac Telemetry
Cleared on Sep 22, 2017 as substantially equivalent to K133701 (Corventis, Inc., 2014) and 1 other predicate after a 333-day review. Its family tree reaches back 11 generations to 1988. 1 later device descends from it.
- Decided
- Sep 22, 2017
- Review
- 333 days
- Class
- Class II
- Product code
- QYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K882803 (1988). 26 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 7 generations between
- 3 generations backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- 2 generations backK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- 1 generation backK133701 Nuvant MCT SystemCorventis, Inc. · 2014
- This deviceK162956 Nowcardio SystemContex International Technologies (Canada), Inc. · 2017
- Descendant · cites it directly · 0 of its ownK182532 Liba3 SystemNational Cardiac, Inc. · 2019
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 backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- 2 generations backK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- 1 generation backK133701 Nuvant MCT SystemCorventis, Inc. · 2014
- This deviceK162956 Nowcardio SystemContex International Technologies (Canada), Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K182532Liba3 SystemNational Cardiac, Inc. · 2019 · cites it directly0descendants
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 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| −2 | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
| −1 | K133701 | Nuvant MCT System | Corventis, Inc. | 2014 | — |
| 0 (this device) | K162956 | Nowcardio System | Contex International Technologies (Canada), Inc. | 2017 | — |
| +1 | K182532 | Liba3 System | National Cardiac, 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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K133701 | Nuvant MCT SystemSummary page 5…and alarm Class: Class II, Special Controls III. PREDICATE DEVICE(S): 1. NUVANT MCT System, cleared February 6, 2014 (NUVANT™ MCT) K133701 - rebranded by Medtronic as SEEQ™ MCT. This is the primary predicate device. 2. BodyGuardian System, manufactur… | 2014 |
| * | K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectSummary page 5…Medtronic as SEEQ™ MCT. This is the primary predicate device. 2. BodyGuardian System, manufactured by Preventice, Inc. and cleared under 510(k) number K121197. IV. DEVICE DESCRIPTION: The NowCardio™ System is a wearable, wireless arrhythmia detection system that pro… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182532 | Liba3 System | 2019 | 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 29 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K182532 (National Cardiac, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K133701.
How does its category compare?
All QYX devicesQYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 NowCardio™ System is an ambulatory cardiac monitoring system prescribed by a physician or other qualified
healthcare professional for out-patient individuals with known non-lethal arrhythmias such as:
• Atrial Fibrillation
• Bradycardia
• Tachycardia
• Pause
It continuously monitors, records, and stores electrocardiographic (ECG) data. If equipped with a transmitter, the
NowCardio™ will also periodically transmit ECG Cardiac Event to a remote computer server. Both recorded and
transmitted ECG data are available to HealthCare Providers for analysis and reporting.
NowCardio™ is intended to be used with adult patients 22 years and older, but not designed for pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162956 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162956: Nowcardio System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162956
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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