510(k) · Cleared
ClearedRX-1 Rhythm Express Remote Cardiac Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VivaQuant, Inc. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Sep 2, 2020 as substantially equivalent to K183704 (VivaQuant, Inc., 2019) and 1 other predicate after a 156-day review. Its family tree reaches back 8 generations to 1988. 1 later device descends from it.
- Decided
- Sep 2, 2020
- Review
- 156 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K882803 (1988). 30 ancestors in all. 1 later device descends from it, 1 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 backK112921 Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012
- 2 generations backK124060 Medical Gorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2013
- 1 generation backK152550 Medicalgorithmics Unified Arrhythmia Diagnosic SystemMedicalgorithmics S.A. · 2015
- This deviceK200833 RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK241179 Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc. · 2025 · 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 | K112921 | Medicalgorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2012 | — |
| −2 | K124060 | Medical Gorithmics Unified Arrhythmia Diagnostic System | Medicalgorithmics S.A. | 2013 | — |
| −1 | K152550 | Medicalgorithmics Unified Arrhythmia Diagnosic System | Medicalgorithmics S.A. | 2015 | — |
| 0 (this device) | K200833 | RX-1 Rhythm Express Remote Cardiac Monitoring System | VivaQuant, Inc. | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 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 |
|---|---|---|---|
| * | K183704 | RX-1 Rhythm Express Remote Cardiac Monitoring SystemSummary page 4…lent in intended use and similar technological characteristics to the following devices: RX-1 Rhythm Express Remote Cardiac Monitoring System cleared under K183704, and PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, cleared under K152550.… | 2019 |
| * | K152550 | Medicalgorithmics Unified Arrhythmia Diagnosic SystemSummary page 4…m Express Remote Cardiac Monitoring System cleared under K183704, and PocketECG III - Medicalgorithmics Unified Arrhythmia Diagnostic System, cleared under K152550. Page 1 of 9… | 2015 |
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 |
|---|---|---|---|
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | 2025 | 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 32 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 30 ancestors has a recall.
- Of its descendants, K241179 (VivaQuant, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 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 (174 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 device for arrhythmia analysis, reporting and signal measurements. The Rhythm Express device is not intended to sound any alarms.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200833 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200833: RX-1 Rhythm Express Remote Cardiac 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/K200833
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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