510(k) · Cleared
ClearedRhythm Express Remote Cardiac Monitoring System (RX-1 mini)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VivaQuant, Inc. · QYX Outpatient Cardiac Telemetry
Cleared on Jul 11, 2025 as substantially equivalent to K200833 (VivaQuant, Inc., 2020) after a 438-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- Jul 11, 2025
- Review
- 438 days
- Class
- Class II
- Product code
- QYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K882803 (1988). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 5 generations between
- 3 generations backK124060 Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013
- 2 generations backK152550 Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A. · 2015
- 1 generation backK200833 RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. · 2020
- This deviceK241179 Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc. · 2025
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 backK112921 Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012
- 3 generations backK124060 Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013
- 2 generations backK152550 Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A. · 2015
- 1 generation backK200833 RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. · 2020
- This deviceK241179 Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc. · 2025
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 | K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2012 | — |
| −3 | K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2013 | — |
| −2 | K152550 | Medicalgorithmics Unified Arrhythmia Diagnosic System | Medicalgorithmics S.A. | 2015 | — |
| −1 | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2020 | — |
| 0 (this device) | K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemSummary page 5…lar Regulatory Class: Class 2 Product Code: QYX, MLO, DSI III. PREDICATE DEVICE RX-1 Rhythm Express Remote Cardiac Monitoring System, K200833. This predicate device has not been subject to a design-related recall. No reference devices were used in this subm… | 2020 |
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 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 31 ancestors has a recall.
How does its category compare?
All QYX devicesQYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded…
Read the full statement (199 words)
The Rhythm Express remote cardiac monitoring system is intended for use by patients greater than 10 kg who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented for review by a medical professional. The data received from the Rhythm Express device can be used by another compatible device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to be used as part of an alarm system or for active patient monitoring.
The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. The Rhythm Express system communicates events from the patient to the monitoring center within one to seven minutes (assuming cell service is available) and hence is not suitable for use as a real-time arrhythmia event monitor.
This device is not intended for patients in whom quantification of triplets/couplets is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241179: Rhythm Express Remote Cardiac Monitoring System (RX-1 mini).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241179
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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