510(k) · Cleared
ClearedMome Ecg Continuous Detection and Arrhythmia Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infobionic, Inc. · QYX Outpatient Cardiac Telemetry
Cleared on Sep 19, 2014 as substantially equivalent to K072558 (Cardionet, Inc., 2007) and 2 other predicates after a 284-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Sep 19, 2014
- Review
- 284 days
- Class
- Class II
- Product code
- QYX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K963725 (1997). 31 ancestors in all, the oldest K843503 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 6 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 5 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 4 generations backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- 3 generations backK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- 2 generations backK081257 CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · Recalled
- 1 generation backK093288 Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010
- This deviceK133753 Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK152491 MoMe Software PlatformInfobionic, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K152491MoMe Software PlatformInfobionic, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −6 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −5 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −4 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −3 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| −2 | K081257 | CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2008 | 2 |
| −1 | K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection | Cardionet, Inc. | 2010 | — |
| 0 (this device) | K133753 | Mome Ecg Continuous Detection and Arrhythmia Detector | Infobionic, Inc. | 2014 | — |
| +1 | K152491 | MoMe Software Platform | Infobionic, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 3 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 Our reading of the summary gave K072588, FDA’s number for Performax SE Total Face Mask (Respironics Inc., Sleep & Home Respiratory Group). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CardioNet ECG Monitoring and Arrhythmia Detection System”. | 2007 |
| * | K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionSummary page 6…System Product Code and Regulation: DSI, 21 CFR 820.1025 MLO, 21 CFR 820.2800 Predicate Device #1: K072588, K093288 CardioNet ECG Monitoring and Arrhythmia Detection System Predicate Device #2: K121197,… | 2010 |
| * | K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectSummary page 6…Predicate Device #1: K072588, K093288 CardioNet ECG Monitoring and Arrhythmia Detection System Predicate Device #2: K121197, Preventice Body Guardian Device Description: The MoMe™ Continuous ECG Monitor and Arrhythmia… | 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 |
|---|---|---|---|
| K152491 | MoMe Software Platform | 2015 | 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 17 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K152491 (Infobionic, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K072558.
How does its category compare?
All QYX devicesQYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for: 1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia. 2. Patients with dizziness or lightheadedness. 3. Patients with palpitations. 4. Patients with syncope of unknown etiology. 5. Patients who require monitoring for non-life threatening…
Read the full statement (207 words)
The MoMe™ Continuous ECG Monitor and Arrhythmia Detector System (MoMe™ System) is indicated for:
1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia.
2. Patients with dizziness or lightheadedness.
3. Patients with palpitations.
4. Patients with syncope of unknown etiology.
5. Patients who require monitoring for non-life threatening arrhythmias, such as atrial fibrillation, other supraventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block.
6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias.
7. Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease.
8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias.
9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation.
The MoMe™ System is contraindicated for:
1. Patients with potentially life threatening arrhythmias who require in-patient monitoring.
2. Patients who the attending physician thinks should be hospitalized.
3. Patients with implanted pacemakers, ICDs, neurostimulators and/or body worn medical devices such as insulin pumps.
Intended Population: For Adult Use Only. The MoMe™ Continuous ECG Monitor and Arrhythmia Detector is intended for patients who are 22 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133753: Mome Ecg Continuous Detection and Arrhythmia Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133753
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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