510(k) · Cleared
ClearedReveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · MXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Cleared on Apr 5, 2023 as substantially equivalent to K210484 (Medtronic, Inc., 2021) after a 121-day review. Its family tree reaches back 15 generations to 1987.
- Decided
- Apr 5, 2023
- Review
- 121 days
- Class
- Class II
- Product code
- MXD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K864889 (1987). 63 ancestors in all, the oldest K832113 (1983). No later device cites it as a predicate yet.
- Root · 15 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 11 generations between
- 3 generations backK162855 Reveal LINQMedtronic, Inc. · 2017 · Recalled
- 2 generations backK200795 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device…Medtronic, Inc. · 2020 · Recalled
- 1 generation backK210484 LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc. · 2021
- This deviceK223630 Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac…Medtronic, Inc. · 2023
Show all 15 generations
- Root · 15 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 14 generations backK950264 MaglifeOdam · 1996
- 13 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 12 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 11 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 10 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 9 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 8 generations backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- 7 generations backK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- 6 generations backK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- 5 generations backK150614 Reveal LINQMedtronic, Inc. · 2015
- 4 generations backK160809 Reveal LINQMedtronic, Inc. · 2016
- 3 generations backK162855 Reveal LINQMedtronic, Inc. · 2017 · Recalled
- 2 generations backK200795 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device…Medtronic, Inc. · 2020 · Recalled
- 1 generation backK210484 LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemMedtronic, Inc. · 2021
- This deviceK223630 Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac…Medtronic, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −14 | K950264 | Maglife | Odam | 1996 | — |
| −13 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −12 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −11 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −10 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −9 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −8 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| −7 | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| −6 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
| −5 | K150614 | Reveal LINQ | Medtronic, Inc. | 2015 | — |
| −4 | K160809 | Reveal LINQ | Medtronic, Inc. | 2016 | — |
| −3 | K162855 | Reveal LINQ | Medtronic, Inc. | 2017 | 1 |
| −2 | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command… | Medtronic, Inc. | 2020 | 3 |
| −1 | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System | Medtronic, Inc. | 2021 | — |
| 0 (this device) | K223630 | Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor… | Medtronic, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
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 K262735 LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)score 16.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210484 | LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification SystemSummary page 4…ent: Arrhythmia Detector and Alarm Predicate Device: LINQ II ICM, Model LNQ22, with AccuRhythm AI ECG Classification System (K210484) K223630… | 2021 |
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 36 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 63 ancestors have a recall of any class.
How does its category compare?
All MXD devicesMXD Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MXD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXD
36in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXD
5so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXD
3,384in 2025
MAUDE reports naming product code MXD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 63 | 0 | 21 |
| 2017 | 4 | 52 | 0 | 37 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 1 | — | 0 | 70 |
| 2020 | 4 | 127 | 0 | 228 |
| 2021 | 4 | 57 | 0 | 694 |
| 2022 | 2 | — | 1 | 1,362 |
| 2023 | 6 | 76 | 1 | 1,766 |
| 2024 | 1 | — | 1 | 3,019 |
| 2025 | 3 | 36 | 0 | 3,384 |
| 2026 | 2 | — | 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.
https://510kreport.com/device/K223630 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223630: Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223630
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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