510(k) Report

510(k) · Cleared

Cleared

V-Patch System

K131000510(k) TraditionalCleared Jan 8, 2014273-day reviewClass II21 CFR 870.1025

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intelesens Limited · DSI Detector And Alarm, Arrhythmia

Cleared on Jan 8, 2014 as substantially equivalent to K100155 (Biomedical Systems Corp., 2010) after a 273-day review. Its family tree reaches back 9 generations to 1988.

Decided
Jan 8, 2014
Review
273 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
1

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.

Other ancestors, by year cleared 2009: 1 other ancestor2008: 3 other ancestors2007: 1 other ancestor1999: 2 other ancestors2006: 1 other ancestor2005: 2 other ancestors2004: 3 other ancestors1998: 2 other ancestors2001: 3 other ancestors2000: 2 other ancestors1996: 2 other ancestors1995: 1 other ancestor1992: 3 other ancestors1988: 1 other ancestor1984: 1 other ancestor1997: 2 other ancestorsK882803 · ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST · Advanced Cardiovascular Systems, Inc. · 1988K012241 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 · Cardionet, Inc. · 2002K052240 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 · Cardionet, Inc. · 2005K063222 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 · Cardionet, Inc. · 2006K072558 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 · Cardionet, Inc. · 2007K083287 · Avivo Mobile Patient Management System · Corventis, Inc. · 2009×2: 2 generations cleared close together, K090696 (2009), K091971 (2009) K100155 · Truvue Wireless Ambulatory Ecg Monitoring System · Biomedical Systems Corp. · 201019801985199019952000200520102015
Other ancestors, by generation 2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 7 other ancestors5 generations back: 14 other ancestors6 generations back: 2 other ancestors7 generations back: 2 other ancestors K100155 · Truvue Wireless Ambulatory Ecg Monitoring System · Biomedical Systems Corp. · 2010K091971 · Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System · Corventis, Inc. · 2009K090696 · Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System · Corventis, Inc. · 2009K083287 · Avivo Mobile Patient Management System · Corventis, Inc. · 2009K072558 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 · Cardionet, Inc. · 2007K063222 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 · Cardionet, Inc. · 2006K052240 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 · Cardionet, Inc. · 2005K012241 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 · Cardionet, Inc. · 2002K882803 · ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST · Advanced Cardiovascular Systems, Inc. · 1988−50
  1. Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
  2. 5 generations between
  3. 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  4. 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  5. 1 generation backK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
  6. This deviceK131000 V-Patch SystemIntelesens Limited · 2014
Show all 9 generations
  1. Root · 9 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
  2. 8 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
  3. 7 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
  4. 6 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
  5. 5 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
  6. 4 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
  7. 3 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  8. 2 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
  9. 1 generation backK100155 Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp. · 2010
  10. This deviceK131000 V-Patch SystemIntelesens Limited · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K882803ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc.1988—
−8K012241Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001Cardionet, Inc.2002—
−7K052240Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc.2005—
−6K063222Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004Cardionet, Inc.2006—
−5K072558Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005Cardionet, Inc.2007—
−4K083287Avivo Mobile Patient Management SystemCorventis, Inc.2009—
−3K090696Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemCorventis, Inc.2009—
−2K091971Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)…Corventis, Inc.2009—
−1K100155Truvue Wireless Ambulatory Ecg Monitoring SystemBiomedical Systems Corp.2010—
0 (this device)K131000V-Patch SystemIntelesens Limited2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198810
199230
199510
199620
199720
199820
199920
200020
200130
200430
200520
200610
200710
200830
200910
FIG. 1 — Lineage of K131000, 1988–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K100155Truvue Wireless Ambulatory Ecg Monitoring System
Summary page 1
…measurement and alarm) OSI, Class 11,CFR 870.1025 Predicate Device: K100155 Biomedical Systems TruVue Device Description:…
Biomedical Systems Corp.2010—

Also cleared against K100155: 2 other devices →

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 26 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.
  • 2 other devices also cite its predicate K100155.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DSI

1in 2025

2007: 72008: 52009: 62010: 62011: 62012: 32013: 12014: 42015: 92016: 62018: 22019: 32020: 22023: 22024: 12025: 12026 (partial year): 1
2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007: 151 days median2008: 70 days median2009: 73 days median2010: 111 days median2011: 114 days median2012: 113 days median2014: 200 days median2015: 127 days median2016: 224 days median2019: 243 days median
2007high 243 (2019) · low 70 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DSI

18in 2025

2007: 42008: 82009: 32010: 52011: 32012: 12018: 12019: 42020: 22022: 12023: 22025: 182026 (partial year): 1
2007high 18 (2025) · low 0 (2013)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DSI

712in 2025

2007: 642008: 1562009: 2792010: 8232011: 7932012: 7662013: 7952014: 1,0002015: 1,6452016: 4,3522017: 3,5942018: 3,6482019: 3,4852020: 3,0842021: 3,0922022: 1,6382023: 1,6162024: 1,3202025: 712
2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077151464
20085708156
20096733279
201061115823
201161143793
201231131766
20131—0795
2014420001,000
2015912701,645
2016622404,352
20170—03,594
20182—13,648
2019324343,485
20202—23,084
20210—03,092
20220—11,638
20232—21,616
20241—01,320
20251—18712
20261—1—

What is it indicated for?

The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by aclinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in ani unmonitored or unobserved situation. The re-usable device is intended to be used…

Read the full statement (159 words)

The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by aclinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in ani unmonitored or unobserved situation.

The re-usable device is intended to be used with a single use electrode on the patient for up to seven days.

The V-Patch-System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of' an arrhythmia event. The V-Patch also has a patient activated button that allows ECG to be recorded and transmitted on-demand should the patient experience any relevant symptoms.

Indications for use as stated in the FDA summary.

Also cleared against K100155

2 other devices cite the same predicate.

  • K160064MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2016
  • K102507Area-CT, TZ Medical Mcot Ecg Monitor and Arrhythmia DetectorTz Medical, Inc. · 2011

More from Intelesens Limited

3 FDA decisions under this applicant name. See the company

  • K151027zensor systemIntelesens Limited · 2015
  • K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 2011

Recent decisions in DSI

The DSI category page

  • K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
  • K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc. · 2025
  • K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc. · 2024
  • K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc. · 2023
  • K231276SmartCardia 7L PlatformSmartcardia SA · 2023

https://510kreport.com/device/K131000 · printed Nov 4, 2026

Cite this page

510(k) Report. “K131000: V-Patch System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131000

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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