510(k) · Cleared
ClearedLifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifewatch Services, Inc. · QYX Outpatient Cardiac Telemetry
Cleared on Aug 1, 2017 as substantially equivalent to K143359 (Lifewatch Technologies, Ltd., 2015) after a 155-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Aug 1, 2017
- Review
- 155 days
- Class
- Class II
- Product code
- QYX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K963725 (1997). 18 ancestors in all, the oldest K843503 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations between
- 3 generations backK101703 Modification to: CG-6108 Act-3L Continuous Ecg Monitor and…Card Guard Scientific Survival, Ltd. · 2010
- 2 generations backK110499 CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2011 · Recalled
- 1 generation backK143359 CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd. · 2015
- This deviceK170565 LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc. · 2017
Show all 9 generations
- Root · 9 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 8 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 7 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 6 generations backK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- 5 generations backK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- 4 generations backK081257 CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2008 · Recalled
- 3 generations backK101703 Modification to: CG-6108 Act-3L Continuous Ecg Monitor and…Card Guard Scientific Survival, Ltd. · 2010
- 2 generations backK110499 CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2011 · Recalled
- 1 generation backK143359 CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies, Ltd. · 2015
- This deviceK170565 LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LLifewatch Services, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −8 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −7 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −6 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| −5 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| −4 | K081257 | CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2008 | 2 |
| −3 | K101703 | Modification to: CG-6108 Act-3L Continuous Ecg Monitor and Arrhythmia… | Card Guard Scientific Survival, Ltd. | 2010 | — |
| −2 | K110499 | CG-5108 Act-3L Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2011 | 2 |
| −1 | K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector | Lifewatch Technologies, Ltd. | 2015 | — |
| 0 (this device) | K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L | Lifewatch Services, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K143359 | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorSummary page 5…Transmitters and Receivers, Electrocardiograph, Telephone Device Classification: 870.1025 870.2920 Predicate Device(s): K143359 CG-6108 ACT 3L Continuous ECG Monitor and Arrhythmia Detector LifeWatch Tec… | 2015 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 18 ancestors have a recall of any class.
How does its category compare?
All QYX devicesQYX Outpatient Cardiac Telemetry: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring…
Read the full statement (159 words)
The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.
The MCT 3L (CG-6108 ACT-3L) Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening.
The device has been validated for use on patients 6 years of age and older.
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/K170565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170565: LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170565
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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