510(k) · Cleared
ClearedCardiacLinx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ross Medical Technology, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Mar 12, 2015 as substantially equivalent to K103706 (Applied Cardiac Systems, Inc., 2011) and 3 other predicates after a 202-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Mar 12, 2015
- Review
- 202 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K963725 (1997). 59 ancestors in all, the oldest K843503 (1984). No later device cites it as a predicate yet.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 4 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 3 generations backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- 2 generations backK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- 1 generation backK103706 The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc. · 2011
- This deviceK142352 CardiacLinxRoss Medical Technology, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −4 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −3 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −2 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| −1 | K103706 | The Core (Cardiac Outpatient Realtime Ecg) Monitor | Applied Cardiac Systems, Inc. | 2011 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K103706 | The Core (Cardiac Outpatient Realtime Ecg) MonitorSummary page 5…te substantial equivalence: 1. Applied Cardiac Systems Cardiac Outpatient Real-time ECG (CORETM) (herein, “The CORE”), cleared by the FDA under 510(k) number K103706; Product Classification Code DSI; Regulation 870.1025. 2. Pulse Biomedical, Inc. (“PBI”) QRS CardTM S-T Segment Analy… | 2011 |
| * | K100813 | QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbSummary page 5…c. (“PBI”) QRS CardTM S-T Segment Analysis Patient Monitoring System Modification (Device Trade Name “QRS Card BT”), cleared by the FDA under 510(k) number K100813; Product Classification Code DPS; Regulation 870.2340. 3. PBI Cardiology Suite 4.0TM Ambulatory ECG Analysis System (herein,… | 2010 |
| * | K042799 | QRS-Card Cardiology SuiteSummary page 5…S; Regulation 870.2340. 3. PBI Cardiology Suite 4.0TM Ambulatory ECG Analysis System (herein, “PBI Cardiology Suite”), cleared by the FDA under 510(k) number K042799; Product Classification Code DQK; Regulation 870.1425. 4. Cardiac Science Corporation Atria 3100/6100 (herein, “Atria… | 2004 |
| * | K060167 | Atria 3100, Atria 6100Summary page 5…tion Code DQK; Regulation 870.1425. 4. Cardiac Science Corporation Atria 3100/6100 (herein, “Atria 3100/6100”), cleared by the FDA under 510(k) number K060167; Product Classification Code DPS; Regulation 870.2340. 510(k) Premarket Notification for CardiacLinx… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 3 of the 59 ancestors have a recall of any class.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
MCT Mode: For 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 notification when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs. Holter Mode: For use on adult patients experiencing palpitations, syncope, pre-syncope…
Read the full statement (278 words)
MCT Mode: For 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 notification when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs.
Holter Mode: For use on adult patients experiencing palpitations, syncope, pre-syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG.
Multi-Lead (Resting EKG) Mode: For 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.
The intended use locations for CardiacLinx are in a physician's office, hospital or rehabilitation facilities, patient’s home, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional.
For general hospital or clinical use by medical professionals whenever an assessment of a patient’s ambulatory ECG data is required. Allows for a trained physician or health care professional to download and analyze the data for review and to produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patient response after resuming occupational or recreational activities (e.g., after myocardial infarction or cardiac surgery), and/or evaluation of patients with pacemakers. CardiacLinx is only available for use upon the order of a physician or other related licensed medical professional.
For use under the supervision of a qualified physician trained in ECG interpretation to record the electrical activity of the heart for the purpose of correlating resultant waveforms with the health of the heart muscle tissue structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142352: CardiacLinx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142352
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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