510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

Reveal LINQ

K162855510(k) TraditionalCleared Feb 23, 2017134-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 23, 2017 as substantially equivalent to K160809 (Medtronic, Inc., 2016) after a 134-day review. Its family tree reaches back 12 generations to 1987. 11 later devices descend from it. It has been recalled once.

Decided
Feb 23, 2017
Review
134 days
Class
Class II
Product code
MXD
Recalls
1
Predicates
1

Its longest line of descent runs back 12 generations to K864889 (1987). 60 ancestors in all, the oldest K832113 (1983). 11 later devices descend from it, 2 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 ancestor2021: 3 descendants cleared2020: 1 descendant cleared2022: 1 descendant cleared2023: 4 descendants 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. · 2011K132649 · Reveal Linq Insertable Cardiac Monitor · Medtronic, Inc. · 2014 · recalledK150614 · Reveal LINQ · Medtronic, Inc. · 2015K160809 · Reveal LINQ · Medtronic, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 4 generations back: 2 other ancestors5 generations back: 6 other ancestors6 generations back: 9 other ancestors7 generations back: 12 other ancestors8 generations back: 15 other ancestors9 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K160809 · Reveal LINQ · Medtronic, Inc. · 2016K150614 · Reveal LINQ · Medtronic, Inc. · 2015K132649 · Reveal Linq Insertable Cardiac Monitor · Medtronic, Inc. · 2014 · recalledK103764 · 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. · 1987−10−50+5
  1. Root · 12 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
  2. 8 generations between
  3. 3 generations backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
  4. 2 generations backK150614 Reveal LINQMedtronic, Inc. · 2015
  5. 1 generation backK160809 Reveal LINQMedtronic, Inc. · 2016
  6. This deviceK162855 Reveal LINQMedtronic, Inc. · 2017
  7. Descendant · cites it directly · 9 of its ownK200795 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device…Medtronic, Inc. · 2020 · Recalled
  8. Descendant · 2 generations on · 4 of its ownK221962 LINQ II Insertable Cardiac MonitorMedtronic, Inc. · 2022 · Recalled
  9. Descendant · 3 generations on · 3 of its ownK233320 LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc. · 2023 · Recalled
  10. Descendant · 4 generations on · 1 of its ownK240693 LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc. · 2024
  11. Descendant · 2 generations on · 1 of its ownK210484 LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc. · 2021
Show all 12 generations
  1. Root · 12 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
  2. 11 generations backK950264 MaglifeOdam · 1996
  3. 10 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
  4. 9 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
  5. 8 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
  6. 7 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
  7. 6 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  8. 5 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
  9. 4 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
  10. 3 generations backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
  11. 2 generations backK150614 Reveal LINQMedtronic, Inc. · 2015
  12. 1 generation backK160809 Reveal LINQMedtronic, Inc. · 2016
  13. This deviceK162855 Reveal LINQMedtronic, Inc. · 2017

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2020: 12021: 32022: 12023: 42024: 12026: 1
2020high 4 (2023) · low 0 (2025)2026

Most influential descendants

Showing 5 of 11 · See all
  • K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc. · 2020 · cites it directly9descendants
  • K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc. · 2022 · 2 generations on4descendants
  • K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc. · 2023 · 3 generations on3descendants
  • K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc. · 2024 · 4 generations on1descendant
  • K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K864889Omni-TrakInvivo Research Labs, Inc.1987—
−11K950264MaglifeOdam1996—
−10K023195Maglife C/Maglife C PlusSchiller Medical S.A.2003—
−9K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc.2004—
−8K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc.2005—
−7K0534623160 Mri Patient Monitoring SystemInvivo Corporation20062
−6K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
−5K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…Medtronic, Inc.2008—
−4K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable…Medtronic, Inc.2011—
−3K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.20141
−2K150614Reveal LINQMedtronic, Inc.2015—
−1K160809Reveal LINQMedtronic, Inc.2016—
0 (this device)K162855Reveal LINQMedtronic, Inc.2017—
+1K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command…Medtronic, Inc.20203
+2K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.20221
+3K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.20231
+4K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.2024—
+2K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc.2021—

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
202010
202130
202210
202340
202410
202610
FIG. 1 — Lineage of K162855, 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? (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
*K160809Reveal LINQ
Summary page 4
…ass II Special Controls Guidance Document: Arrhythmia Detector and Alarm Predicate Devices: Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) K160809 Reveal LINQ with TruRhythm LINQ FW 2.0 K…
Medtronic, Inc.2016—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc.20209
K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 1, 2021Class IIZ-2102-2021Software designReveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
  • 4 of the 60 ancestors have a recall of any class.
  • Of its descendants, K200795 (Medtronic, Inc., 2020) has gone furthest, with 9 descendants of its own.

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. 2017, 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 ICM is an insertable automatically-activated and patient-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 device has not been tested specifically for pediatric use.

Indications for use as stated in the FDA summary.

More from Medtronic, Inc.

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

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  • 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/K162855 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162855: Reveal LINQ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162855

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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