510(k) · Cleared
ClearedArea-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tz Medical, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jun 13, 2011 as substantially equivalent to K072558 (Cardionet, Inc., 2007) and 1 other predicate after a 285-day review. Its family tree reaches back 9 generations to 1988.
- Decided
- Jun 13, 2011
- Review
- 285 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K882803 (1988). 39 ancestors in all, the oldest K843503 (1984). No later device cites it as a predicate yet.
- Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 5 generations between
- 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 1 generation backK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
- This deviceK102507 Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc. · 2011
Show all 9 generations
- Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 8 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 7 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 6 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 5 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 4 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 1 generation backK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
- This deviceK102507 Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −8 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −7 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −6 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −5 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −4 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −3 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −2 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| −1 | K100155 | Truvue Wireless Ambulatory Ecg Monitoring System | Biomedical Systems Corp. | 2010 | — |
| 0 (this device) | K102507 | Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia Detector | Tz Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 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 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? (2)
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 |
|---|---|---|---|
| * | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005Summary page 1…Class 11with Special Controls Panel: 74 Circulatory System Devices 3. Predicate Devices K072558 CardioNet ECG Monitor with Arrhythmia Detector Model CN100S K100155 Biomedical Systems In… | 2007 |
| * | K100155 | Truvue Wireless Ambulatory Ecg Monitoring SystemSummary page 1…74 Circulatory System Devices 3. Predicate Devices K072558 CardioNet ECG Monitor with Arrhythmia Detector Model CN100S K100155 Biomedical Systems Inc. Monitor with Arrhythmia Detector Model TruVue 4. Indications for Use and Contraindica… | 2010 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 39 ancestors have a recall of any class.
- 7 other devices also cite its predicate K072558.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RE Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.…
Read the full statement (336 words)
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RE Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.
Patients include, but are not limited to, those requiring monitoring for
a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT) and ventricular ectopy,
b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and
c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
Patients with symptoms that may be due to cardiac arrhythmias. These may include, but are not limited to, symptoms such as
a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded,
b) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms.
Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation).
Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral schemnia, possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes.
Contra ind ications:
Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
Patients who the attending physician thinks should be hospitalized.
Note:
The Aera CT system does not provide interpretive or diagnostic statements. Interpretation and diagnosis is the sponsibility of a trained healthcare professional or physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102507: Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102507
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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