510(k) · Cleared
ClearedThe Core (Cardiac Outpatient Realtime Ecg) Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Cardiac Systems, Inc. · QYX Outpatient Cardiac Telemetry
Cleared on Aug 24, 2011 as substantially equivalent to K071995 (Card Guard Scientific Survival, Ltd., 2007) and 5 other predicates after a 247-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Aug 24, 2011
- Review
- 247 days
- Class
- Class II
- Product code
- QYX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K963725 (1997). 37 ancestors in all, the oldest K843503 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 3 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 2 generations backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- 1 generation backK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- This deviceK103706 The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142352CardiacLinxRoss Medical Technology, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −3 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −2 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −1 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| 0 (this device) | K103706 | The Core (Cardiac Outpatient Realtime Ecg) Monitor | Applied Cardiac Systems, Inc. | 2011 | — |
| +1 | K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (6)
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 |
|---|---|---|---|
| * | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorSummary page 5…monstrate substantial equivalence: 1. Card Guard Scientific Survival, Ltd. CG-6108 Continuous ECG Monitor & Arrhythmia Detector, cleared by the FDA under 510(k} number K071995; Product Classification Code DSl, Regulation 870.1025. 2. Card Guard Scientific Survival, Ltd. King Of Hearts Express+AF monitor… | 2007 |
| * | K020825 | King of Hearts Express + AF MonitorSummary page 5…Product Classification Code DSl, Regulation 870.1025. 2. Card Guard Scientific Survival, Ltd. King Of Hearts Express+AF monitor, cleared by the FDA under 510(k) number K020825 Product Classification Code DSH, Regulation 870.2800. 3. Monebo Technologies, Inc. Monebo Automated ECG Analysis And Interpret… | 2002 |
| * | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Summary page 5…ulation 870.2800. 3. Monebo Technologies, Inc. Monebo Automated ECG Analysis And Interpretation Software Library, Version 3.0, cleared by the FDA under 510(k) number K062282 Product Classification Code DPS, Regulation 870.2340. 4. Applied Cardiac System The Holter Reporter as cleared by the FDA under… | 2007 |
| * | K860249 | The Holter Reporter (TM)Summary page 5…der 510(k) number K062282 Product Classification Code DPS, Regulation 870.2340. 4. Applied Cardiac System The Holter Reporter as cleared by the FDA under 510(k) number K860249; Product Classification Code DPS, Regulation 870.2340. 8/9/11 Page5-1 Rev.5 K103 py2of2e Applied Cardiac Syst… | 1986 |
| * | K102723 | Model 950-12L Holter Recorder Without AnalysisSummary page 6…e 6 === K103 py2of2e Applied Cardiac Systems Section 5: 510(k) Summary - Abbreviated Submission 5. Memtec Corp. Model 950-12L as cleared by the FDA under 510(k) number K102723; Product Classification Code MWJ, Regulation 870.2800. 6. Burdick Corp. EK10 Electrocardiograph (non-interpretive), as cleared b… | 2010 |
| * | K870880 | EK10 ElectrocardiographSummary page 6…er K102723; Product Classification Code MWJ, Regulation 870.2800. 6. Burdick Corp. EK10 Electrocardiograph (non-interpretive), as cleared by the FDA under 510(k) number K870880; Product Classification Code DPS, Regulation 870.2340. Device Description: The ACS Cardiac Outpatient Real Time ECG {CORE™) mon… | 1987 |
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 |
|---|---|---|---|
| K142352 | CardiacLinx | 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 14 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 2 of the 37 ancestors have a recall of any class.
- Of its descendants, K142352 (Ross Medical Technology, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071995.
How does its category compare?
All QYX devicesQYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmias. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs. 2. Holter Mode: Use on adult patients experiencing palpitations, syncope…
Read the full statement (179 words)
1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmias. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs.
2. Holter Mode: Use on adult patients experiencing palpitations, syncope, pre-Syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG.
3. Multi-Lead (Resting EKG) Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.
Contra-indications for use:
1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring; and patients who the attending physician thinks should be hospitalized.
The device continuously monitors patient's ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center.
The software does not perform diagnosis. The ECG data is provided to the medical practitioner for evaluation and diagnosis.
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/K103706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103706: The Core (Cardiac Outpatient Realtime Ecg) Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103706
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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