510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Reveal Linq Insertable Cardiac Monitor

K132649510(k) TraditionalCleared Feb 14, 2014172-day reviewClass II21 CFR 870.1025Recalls 1

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

Medtronic, Inc. · MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)

Cleared on Feb 14, 2014 as substantially equivalent to K071641 (Medtronic, Inc., 2007) and 3 other predicates after a 172-day review. Its family tree reaches back 9 generations to 1987. 23 later devices descend from it. It has been recalled once.

Decided
Feb 14, 2014
Review
172 days
Class
Class II
Product code
MXD
Recalls
1
Predicates
4

Its longest line of descent runs back 9 generations to K864889 (1987). 57 ancestors in all, the oldest K832113 (1983). 23 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2002: 2 other ancestors2005: 1 other ancestor2001: 3 other ancestors2000: 3 other ancestors1999: 7 other ancestors1992: 2 other ancestors2004: 2 other ancestors2003: 1 other ancestor1998: 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 ancestor2017: 4 descendants cleared2020: 2 descendants cleared2015: 1 descendant cleared2016: 2 descendants cleared2019: 1 descendant cleared2023: 5 descendants cleared2021: 4 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant 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) K071641 · Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) · Medtronic, Inc. · 2007K082475 · Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 · Medtronic, Inc. · 2008K103764 · Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 · Medtronic, Inc. · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 9 other ancestors4 generations back: 12 other ancestors5 generations back: 15 other ancestors6 generations back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 3 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K103764 · Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 · Medtronic, Inc. · 2011K082475 · Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 · Medtronic, Inc. · 2008K071641 · Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) · Medtronic, Inc. · 2007K053462 · 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 · 9 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
  2. 5 generations between
  3. 3 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  4. 2 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
  5. 1 generation backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
  6. This deviceK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014
  7. Descendant · cites it directly · 15 of its ownK150614 Reveal LINQMedtronic, Inc. · 2015
  8. Descendant · 2 generations on · 12 of its ownK160809 Reveal LINQMedtronic, Inc. · 2016
  9. Descendant · 3 generations on · 11 of its ownK162855 Reveal LINQMedtronic, Inc. · 2017 · Recalled
  10. Descendant · 4 generations on · 9 of its ownK200795 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device…Medtronic, Inc. · 2020 · Recalled
  11. Descendant · 5 generations on · 4 of its ownK221962 LINQ II Insertable Cardiac MonitorMedtronic, Inc. · 2022 · Recalled
Show all 9 generations
  1. Root · 9 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
  2. 8 generations backK950264 MaglifeOdam · 1996
  3. 7 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
  4. 6 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
  5. 5 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
  6. 4 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
  7. 3 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  8. 2 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
  9. 1 generation backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
  10. This deviceK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2015: 12016: 22017: 42019: 12020: 22021: 42022: 12023: 52024: 12025: 12026: 1
2015high 5 (2023) · low 0 (2018)2026

Most influential descendants

Showing 5 of 23 · See all
  • K150614Reveal LINQMedtronic, Inc. · 2015 · cites it directly15descendants
  • K160809Reveal LINQMedtronic, Inc. · 2016 · 2 generations on12descendants
  • K162855Reveal LINQMedtronic, Inc. · 2017 · 3 generations on11descendants
  • K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc. · 2020 · 4 generations on9descendants
  • K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc. · 2022 · 5 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K864889Omni-TrakInvivo Research Labs, Inc.1987—
−8K950264MaglifeOdam1996—
−7K023195Maglife C/Maglife C PlusSchiller Medical S.A.2003—
−6K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc.2004—
−5K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc.2005—
−4K0534623160 Mri Patient Monitoring SystemInvivo Corporation20062
−3K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
−2K082475Reveal 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—
0 (this device)K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.2014—
+1K150614Reveal LINQMedtronic, Inc.2015—
+2K160809Reveal LINQMedtronic, Inc.2016—
+3K162855Reveal LINQMedtronic, Inc.20171
+4K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command…Medtronic, Inc.20203
+5K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.20221

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
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201620
201740
201910
202020
202140
202210
202350
202410
202510
202610
FIG. 1 — Lineage of K132649, 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 MXD? 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 MXD device

  1. #1 K262735 LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)score 16.7 · 17 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)
Summary page 1
…to the following predicate devices: " The Reveal XT (Model 9529) and Reveal DX (Model 9528) were initially cleared via separate 510(k) applications, reference numbers K07 1641, K07 1655 on November 21, 2007. The Reveal XT (Model 9529) and Reveal DX (Model 9528) most recent modifications submission we…
Medtronic, Inc.2007—
*K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538
Summary page 1
…llowing predicate devices: " The Reveal XT (Model 9529) and Reveal DX (Model 9528) were initially cleared via separate 510(k) applications, reference numbers K07 1641, K07 1655 on November 21, 2007. The Reveal XT (Model 9529) and Reveal DX (Model 9528) most recent modifications submission were cleared…
Medtronic, Inc.2007—
*K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…
Summary page 1
…eference numbers K07 1641, K07 1655 on November 21, 2007. The Reveal XT (Model 9529) and Reveal DX (Model 9528) most recent modifications submission were cleared via K 103764 on May 4, 2011. * Instromedix King of H-earts Express AF Recorder - K020825, Cleared April 5,2002 Device Description The Reve…
Medtronic, Inc.2011—
*K020825King of Hearts Express + AF Monitor
Summary page 1
…l 9529) and Reveal DX (Model 9528) most recent modifications submission were cleared via K 103764 on May 4, 2011. * Instromedix King of H-earts Express AF Recorder - K020825, Cleared April 5,2002 Device Description The Reveal LINQ Model ENQI I Insertable Cardiac Monitors (1CM) is designed to automati…
Card Guard Scientific Survival, Ltd.2002—

Also cleared against K071641: 5 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K150614Reveal LINQMedtronic, Inc.201515
K193473LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic…Boston Scientific Corporation20203
K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc.20172

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 23, 2016Class IIZ-1249-2016Software designMedtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ ICM that may prematurely trigger the Recommended Replacement Time (RRT) alert in some devices. Battery capacity is not affected and the device…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 3 of the 57 ancestors have a recall of any class.
  • Of its descendants, K150614 (Medtronic, Inc., 2015) has gone furthest, with 15 descendants of its own.
  • 5 other devices also cite its predicate K071641.

How does its category compare?

All MXD devices

MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MXD

3in 2025

2014: 22015: 22016: 32017: 42019: 12020: 42021: 42022: 22023: 62024: 12025: 32026 (partial year): 2
2007high 6 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MXD

36in 2025

2016: 63 days median2017: 52 days median2020: 127 days median2021: 57 days median2023: 76 days median2025: 36 days median
2007high 127 (2020) · low 36 (2025)2026

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

Recalls per year · MXD

5so far in 2026, the most since 2007

2022: 12023: 12024: 12026 (partial year): 5
2007high 5 (2026) · low 0 (2007)2026

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

Adverse event reports per year · MXD

3,384in 2025

2013: 12015: 22016: 212017: 372018: 322019: 702020: 2282021: 6942022: 1,3622023: 1,7662024: 3,0192025: 3,384
2007high 3,384 (2025) · low 0 (2007)2025

MAUDE reports naming product code MXD, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—01
20142—00
20152—02
2016363021
2017452037
20180—032
20191—070
202041270228
20214570694
20222—11,362
202367611,766
20241—13,019
202533603,384
20262—5—

What is it indicated for?

The Reveal LINQ 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 such as dizziness, palpitation, syncope and chest pain that may suggest a cardiac arrhythmia.

The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal LINQ ICM to initiate recording of cardiac event data in the implanted device memory.

Indications for use as stated in the FDA summary.

Also cleared against K071641

5 other devices cite the same predicate.

  • K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library…Medtronic, Inc. · 20203 recalls
  • K143503BioMonitorBiotronik, Inc. · 2015
  • K132960BiomonitorBiotronik, Inc. · 2014
  • K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528Medtronic, Inc. · 2011
  • K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528Medtronic, Inc. · 2008

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 MXD

The MXD category page

  • K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc. · 2026
  • K261074Biomonitor IV (471155)Biotronik, Inc. · 2026
  • K253516Assert-IQ (DM5100)Abbott Medical · 2025
  • K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott · 2025
  • K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation · 2025

https://510kreport.com/device/K132649 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132649: Reveal Linq Insertable Cardiac Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132649

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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