510(k) · Cleared
ClearedHeartlink, Model II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Telecom Corp. · QYX Outpatient Cardiac Telemetry
Cleared on Nov 13, 1998 as substantially equivalent to K934913 (Cardiac Telecom Corp., 1995) and 2 other predicates after a 95-day review. Its family tree reaches back 1 generation to 1984. 26 later devices descend from it.
- Decided
- Nov 13, 1998
- Review
- 95 days
- Class
- Class II
- Product code
- QYX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K843503 (1984). 3 ancestors in all. 26 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK843503 Aegis Ambulatory Monitoring SystemAegis Medical Systems, Inc. · 1984
- This deviceK982803 Heartlink, Model IICardiac Telecom Corp. · 1998
- Descendant · cites it directly · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK081257 CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · Recalled
- Descendant · 3 generations on · 7 of its ownK093288 Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK090037 Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector…Medicalgorithmics SP Z.O.O. · 2009
- Descendant · 3 generations on · 6 of its ownK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · cites it directly25descendants
- K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · 2 generations on18descendants
- K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010 · 3 generations on7descendants
- K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O. · 2009 · 2 generations on7descendants
- K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843503 | Aegis Ambulatory Monitoring System | Aegis Medical Systems, Inc. | 1984 | — |
| 0 (this device) | K982803 | Heartlink, Model II | Cardiac Telecom Corp. | 1998 | — |
| +1 | 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 |
| +3 | K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection | Cardionet, Inc. | 2010 | — |
| +2 | K090037 | Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model Pocketecg | Medicalgorithmics SP Z.O.O. | 2009 | — |
| +3 | K100155 | Truvue Wireless Ambulatory Ecg Monitoring System | Biomedical Systems Corp. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K934913 | Heartrac Ecg Monitoring SystemSummary page 7…r and receiver (21 C.F.R. § 870.2920) Arrhythmia detector and alarm (21 CFR §870.1025) 27 10.3. Predicate or Legally Marketed Devices: e HEARTLIink I (K934913) Cardiac Telecom Corporation (Turtle Creek, PA) « King of Hearts (K880626) Instromedix, Inc (Hilisboro, OR) e Aegis (K843503)… | 1995 |
| * | K880626 | King of HeartsSummary page 7…R §870.1025) 27 10.3. Predicate or Legally Marketed Devices: e HEARTLIink I (K934913) Cardiac Telecom Corporation (Turtle Creek, PA) « King of Hearts (K880626) Instromedix, Inc (Hilisboro, OR) e Aegis (K843503) Medical Concepts, Inc (Gibbsboro, NJ) 10.4. Device Description: The HEART… | 1988 |
| * | K843503 | Aegis Ambulatory Monitoring SystemSummary page 7…Legally Marketed Devices: e HEARTLIink I (K934913) Cardiac Telecom Corporation (Turtle Creek, PA) « King of Hearts (K880626) Instromedix, Inc (Hilisboro, OR) e Aegis (K843503) Medical Concepts, Inc (Gibbsboro, NJ) 10.4. Device Description: The HEARTLink II System receives and processes radiofrequency… | 1984 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | 2007 | 25 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K071995 (Card Guard Scientific Survival, Ltd., 2007) has gone furthest, with 25 descendants of its own.
How does its category compare?
All QYX devicesQYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years.
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. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia,
2. Specific criteria for indications for use are as follows:
Patients requiring monitoring for arrhythmia-inducing co-morbid conditions such as
Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias
Patients requiring arrhythmia evaluation for etiology of stroke or Transient cerebral ischemia,
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/K982803 · printed Nov 3, 2026
Cite this page
510(k) Report. “K982803: Heartlink, Model II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K982803
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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