510(k) · Cleared
ClearedHeartrac Ecg Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Telecom Corp. · QYW Hospital Cardiac Telemetry
Cleared on Jun 5, 1995 after a 598-day review. The FDA summary names no predicate by number. 27 later devices descend from it.
- Decided
- Jun 5, 1995
- Review
- 598 days
- Class
- Class II
- Product code
- QYW
- Recalls
- None
- Predicates
- 0
27 later devices descend from it, 1 citing it directly.
- This deviceK934913 Heartrac Ecg Monitoring SystemCardiac Telecom Corp. · 1995
- Descendant · cites it directly · 26 of its ownK982803 Heartlink, Model IICardiac Telecom Corp. · 1998
- Descendant · 2 generations on · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 18 of its ownK081257 CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · Recalled
- Descendant · 4 generations on · 7 of its ownK093288 Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010
- Descendant · 3 generations on · 7 of its ownK090037 Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector…Medicalgorithmics SP Z.O.O. · 2009
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K982803Heartlink, Model IICardiac Telecom Corp. · 1998 · cites it directly26descendants
- K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · 2 generations on25descendants
- K081257CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · 3 generations on18descendants
- K093288Cardionet Ambulatory Ecg Monitor with Arrhythmia DetectionCardionet, Inc. · 2010 · 4 generations on7descendants
- K090037Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model PocketecgMedicalgorithmics SP Z.O.O. · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934913 | Heartrac Ecg Monitoring System | Cardiac Telecom Corp. | 1995 | — |
| +1 | K982803 | Heartlink, Model II | Cardiac Telecom Corp. | 1998 | — |
| +2 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| +3 | K081257 | CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2008 | 2 |
| +4 | K093288 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection | Cardionet, Inc. | 2010 | — |
| +3 | K090037 | Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model Pocketecg | Medicalgorithmics SP Z.O.O. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 QYW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982803 | Heartlink, Model II | 1998 | 26 |
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?
- Of its descendants, K982803 (Cardiac Telecom Corp., 1998) has gone furthest, with 26 descendants of its own.
How does its category compare?
All QYW devicesQYW Hospital Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · QYW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · QYW
Too few QYW 510(k)s in any year since 2007 to give a median.
Recalls per year · QYW
No recall names QYW since 2007.
Adverse event reports per year · QYW
No MAUDE report names QYW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 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 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K934913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934913: Heartrac Ecg 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/K934913
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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