510(k) Report

510(k) · Cleared

Cleared

Reveal Plus Insertable Loop Recorder

K003667510(k) TraditionalCleared Feb 14, 200178-day reviewClass II21 CFR 870.2800

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

Medtronic Vascular · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Cleared on Feb 14, 2001 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.

Decided
Feb 14, 2001
Review
78 days
Class
Class II
Product code
MXC
Recalls
None
Predicates
0

47 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2009: 2 descendants cleared2015: 3 descendants cleared2014: 3 descendants cleared2011: 1 descendant cleared2008: 1 descendant cleared2020: 4 descendants cleared2012: 1 descendant 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 cleared200020052010201520202025
  1. This deviceK003667 Reveal Plus Insertable Loop RecorderMedtronic Vascular · 2001
  2. Descendant · cites it directly · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  3. Descendant · cites it directly · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
  4. Descendant · 2 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
  5. Descendant · 2 generations on · 26 of its ownK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
  6. Descendant · 2 generations on · 23 of its ownK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2007: 42008: 12009: 22011: 12012: 12014: 32015: 32016: 32017: 62019: 32020: 42021: 42022: 22023: 62024: 12025: 12026: 2
2007high 6 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 47 · See all
  • K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · cites it directly40descendants
  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · cites it directly30descendants
  • K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 2 generations on28descendants
  • K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · 2 generations on26descendants
  • K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003667Reveal Plus Insertable Loop RecorderMedtronic Vascular2001—
+1K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
+1K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…Medtronic, Inc.2007—
+2K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…Medtronic, Inc.2008—
+2K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable…Medtronic, Inc.2011—
+2K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc.20141

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200740
200810
200920
201110
201210
201430
201530
201630
201760
201930
202040
202140
202220
202360
202410
202510
202620
FIG. 1 — Lineage of K003667, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MXC? 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 MXC device

  1. #1 K230286 Assert-IQ™ Insertable Cardiac Monitorscore 9.6 · 5 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (47)

See all 47

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

NumberDeviceApplicantDecidedDescendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc.200740
K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc.200730
K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc.20073

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?

  • Of its descendants, K071641 (Medtronic, Inc., 2007) has gone furthest, with 40 descendants of its own.

How does its category compare?

All MXC devices

MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MXC

1in 2023

2007: 22008: 12009: 22010: 12012: 22014: 12017: 22019: 32020: 32021: 12023: 1
2007high 3 (2019) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MXC

64in 2020

2019: 58 days median2020: 64 days median
2007high 64 (2020) · low 58 (2019)2026

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

Recalls per year · MXC

1in 2018

2011: 12018: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MXC

1,105in 2025

2008: 32009: 122010: 142011: 212012: 302013: 1442014: 5982015: 2352016: 1942017: 2262018: 1,8192019: 1,5932020: 1,1002021: 8322022: 6282023: 8282024: 9752025: 1,105
2007high 1,819 (2018) · low 0 (2007)2025

MAUDE reports naming product code MXC, 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
20072—00
20081—03
20092—012
20101—014
20110—121
20122—030
20130—0144
20141—0598
20150—0235
20160—0194
20172—0226
20180—11,819
201935801,593
202036401,100
20211—0832
20220—0628
20231—0828
20240—0975
20250—01,105
20260—0—

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  • P160043/S094Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026
  • P160043/S093Resolute Onyx Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular · 2026
  • P160043/S092Resolute Onyx Zotarolimus-Eluting Coronary Stent System; Onyx Frontier Zotarolimus-Eluting Coronary Stent…Medtronic Vascular · 2026

Recent decisions in MXC

The MXC category page

  • K230286Assert-IQ™ Insertable Cardiac MonitorAbbott Medical · 2023
  • K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2021
  • K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020
  • K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) · 2020
  • K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical) · 2020

https://510kreport.com/device/K003667 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003667: Reveal Plus Insertable Loop Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003667

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026