510(k) Report

510(k) · Cleared

Cleared

Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)

K071641510(k) TraditionalCleared Nov 21, 2007159-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

Medtronic, Inc. · DSI Detector And Alarm, Arrhythmia

Cleared on Nov 21, 2007 as substantially equivalent to K994331 (Medtronic Vascular, 2000) and 5 other predicates after a 159-day review. Its family tree reaches back 6 generations to 1987. 40 later devices descend from it.

Decided
Nov 21, 2007
Review
159 days
Class
Class II
Product code
DSI
Recalls
None
Predicates
6

Its longest line of descent runs back 6 generations to K864889 (1987). 53 ancestors in all, the oldest K832113 (1983). 40 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 2 other ancestors2001: 3 other ancestors2000: 3 other ancestors1999: 7 other ancestors2004: 2 other ancestors2003: 1 other ancestor1992: 2 other ancestors1998: 2 other ancestors1996: 3 other ancestors1995: 7 other ancestors1994: 3 other ancestors1986: 1 other ancestor1997: 2 other ancestors1993: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor1983: 1 other ancestor1987: 1 other ancestor2015: 3 descendants cleared2014: 3 descendants cleared2011: 1 descendant cleared2008: 1 descendant cleared2020: 4 descendants cleared2017: 6 descendants cleared2016: 3 descendants cleared2022: 2 descendants cleared2021: 4 descendants cleared2019: 3 descendants cleared2023: 6 descendants cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants clearedK864889 · Omni-Trak · Invivo Research Labs, Inc. · 1987K950264 · Maglife · Odam · 1996K023195 · Maglife C/Maglife C Plus · Schiller Medical S.A. · 2003K040915 · Magnitude 3150M Mri Patient Monitor, Model 3150M · Invivo Research, Inc. · 2004×2: 2 generations cleared close together, K050399 (2005), K053462 (2006) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 11 other ancestors3 generations back: 12 other ancestors4 generations back: 15 other ancestors5 generations back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 13 descendants4 generations forward: 6 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant K053462 · 3160 Mri Patient Monitoring System · Invivo Corporation · 2006 · recalledK050399 · Mri Compatible Patient Monitoring System, Model 3160 · Invivo Research, Inc. · 2005K040915 · Magnitude 3150M Mri Patient Monitor, Model 3150M · Invivo Research, Inc. · 2004K023195 · Maglife C/Maglife C Plus · Schiller Medical S.A. · 2003K950264 · Maglife · Odam · 1996K864889 · Omni-Trak · Invivo Research Labs, Inc. · 1987−50+5
  1. Root · 6 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
  2. 5 generations backK950264 MaglifeOdam · 1996
  3. 4 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
  4. 3 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
  5. 2 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
  6. 1 generation backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
  7. This deviceK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  8. Descendant · cites it directly · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
  9. Descendant · cites it directly · 26 of its ownK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
  10. Descendant · cites it directly · 23 of its ownK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
  11. Descendant · 2 generations on · 15 of its ownK150614 Reveal LINQMedtronic, Inc. · 2015
  12. Descendant · 3 generations on · 12 of its ownK160809 Reveal LINQMedtronic, Inc. · 2016

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12014: 32015: 32016: 32017: 62019: 32020: 42021: 42022: 22023: 62024: 12025: 12026: 2
2008high 6 (2017) · low 0 (2009)2026

Most influential descendants

Showing 5 of 40 · See all
  • K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · cites it directly28descendants
  • K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · cites it directly26descendants
  • K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · cites it directly23descendants
  • K150614Reveal LINQMedtronic, Inc. · 2015 · 2 generations on15descendants
  • K160809Reveal LINQMedtronic, Inc. · 2016 · 3 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K864889Omni-TrakInvivo Research Labs, Inc.1987—
−5K950264MaglifeOdam1996—
−4K023195Maglife C/Maglife C PlusSchiller Medical S.A.2003—
−3K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc.2004—
−2K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc.2005—
−1K0534623160 Mri Patient Monitoring SystemInvivo Corporation20062
0 (this device)K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
+1K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…Medtronic, Inc.2008—
+1K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable…Medtronic, Inc.2011—
+1K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.20141
+2K150614Reveal LINQMedtronic, Inc.2015—
+3K160809Reveal LINQMedtronic, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
198610
198710
198810
198910
199010
199110
199220
199320
199430
199570
199630
199720
199820
199970
200030
200130
200220
200310
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201430
201530
201630
201760
201930
202040
202140
202220
202360
202410
202510
202620
FIG. 1 — Lineage of K071641, 1987–2026Source: 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? (6)

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
*K994331Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model…
Summary page 2
…Assistant (Model 9539) are substantially equivalent to the tbl1owing predicate devices. • Medtronic Model 6 19 1 Patient Activator - K99433 1. Cleared 21 ,Ianuary 2000 * hnstronmedix King of Hearts Express AF Recorder - K020825. Cleared 05 April…
Medtronic Vascular2000—
*K003667Reveal Plus Insertable Loop Recorder
Summary page 1
…following predicate devices: * Medtronic Reveal PIlus (Model 95i26) ILR - K(99433 I. Cleared 21 JanLuarv 2000/K003667, Cleared 14 February 2100I * Instrormedix King- offHearts Express AU' Recorder - 1(020825. Cleared 05 April…
Medtronic Vascular2001—
*K020825King of Hearts Express + AF Monitor
Summary page 2
…s. • Medtronic Model 6 19 1 Patient Activator - K99433 1. Cleared 21 ,Ianuary 2000 * hnstronmedix King of Hearts Express AF Recorder - K020825. Cleared 05 April 2002/ K003667. Cleared 14 February 2001 Device Description The Reveal XT Mo…
Card Guard Scientific Survival, Ltd.2002—
*K042108Vista PlusNovacor2005—
*K992410ActitracIndividual Monitoring Systems, Inc.1999—
*K0534623160 Mri Patient Monitoring System
Summary page 1
…red 1-5) October 999 * Invivo Corporation Model 3)160 MRI Patient Monitor (MR[ compatible mnultiparanmeter patient monitor) -. 1053462, Cleared IX January 2005 MeditroniC Confidential…
Invivo Corporation20062

Also cleared against K994331: 3 other devices →

What descends from it? (40)

See all 40

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc.200828
K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc.201126
K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.201423
K132960BiomonitorBiotronik, Inc.201410
K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.20209
K143503BioMonitorBiotronik, Inc.20159

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 6 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 53 ancestors have a recall of any class.
  • Of its descendants, K082475 (Medtronic, Inc., 2008) has gone furthest, with 28 descendants of its own.
  • 3 other devices also cite its predicate K994331.

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. 2007, 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 Reveal XT Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: - patients with clinical syndromes or situations at increased risk of cardiac arrhythmias * patients who experience transient symptoms that may suggest a cardiac arrhythmia The Reveal XT Patient Assistant is intended for unsupervised patient use away from a…

Read the full statement (114 words)

The Reveal XT Insertable Cardiac Monitor is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

- patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

* patients who experience transient symptoms that may suggest a cardiac arrhythmia

The Reveal XT Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:

* To verify whether the implanted device has detected a suspected arrhythmia or device related event.

* To initiate recording of cardiac event data in the implanted device memory.

Indications for use as stated in the FDA summary.

Also cleared against K994331

3 other devices cite the same predicate.

  • K081365SJM Confirm Model DM2100 Implantable Cardiac Monitor and Model DM2100A Patient ActivatorSt Jude Medical · 20081 recall
  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007
  • K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007

More from Medtronic, Inc.

6,442 FDA decisions under this applicant name. See the company

  • P220026/S019Symplicity G3 Renal Denervation RF GeneratorMedtronic, Inc. · 2026
  • P240036/S007OmniaSecure™ MRI SureScan™ Lead Model 3930MMedtronic, Inc. · 2026
  • P010015/S591Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena…Medtronic, Inc. · 2026
  • P980035/S848Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG…Medtronic, Inc. · 2026
  • P860004/S462SynchroMed™ Infusion System, Ascenda ™ Intrathecal CathetersMedtronic, Inc. · 2026

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/K071641 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071641

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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