510(k) · Cleared
ClearedReveal Insertable Loop Recorder (Ilr) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cleared on Jan 16, 1998 after a 214-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 16, 1998
- Review
- 214 days
- Class
- Class II
- Product code
- MXC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK972242 Reveal Insertable Loop Recorder (Ilr) SystemMedtronic Vascular · 1998
- Descendant · cites it directly · 3 of its ownK063035 Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK073147 Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007
- Descendant · 2 generations on · 1 of its ownK083828 Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM…Transoma · 2009
- Descendant · 3 generations on · 0 of its ownK091206 Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna…Transoma Medical · 2009
Most influential descendants
Showing 4 of 4 · See all- K063035Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007 · cites it directly3descendants
- K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007 · 2 generations on2descendants
- K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma · 2009 · 2 generations on1descendant
- K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972242 | Reveal Insertable Loop Recorder (Ilr) System | Medtronic Vascular | 1998 | — |
| +1 | K063035 | Sleuth Implantable Ecg Monitoring System | Transnoma Medical, Inc. | 2007 | — |
| +2 | K073147 | Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08 | Transoma Medical | 2007 | — |
| +2 | K083828 | Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna… | Transoma | 2009 | — |
| +3 | K091206 | Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal… | Transoma Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 2 | 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 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 K230286 Assert-IQ™ Insertable Cardiac Monitorscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Instromedix King of Hearts Express 3X Named without a submission number | |
| * | — | Medtronic Minix implantable pulse generator Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063035 | Sleuth Implantable Ecg Monitoring System | 2007 | 3 |
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, K063035 (Transnoma Medical, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MXC devicesMXC 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MXC
64in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MXC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXC
1,105in 2025
MAUDE reports naming product code MXC, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 1 | — | 0 | 14 |
| 2011 | 0 | — | 1 | 21 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 144 |
| 2014 | 1 | — | 0 | 598 |
| 2015 | 0 | — | 0 | 235 |
| 2016 | 0 | — | 0 | 194 |
| 2017 | 2 | — | 0 | 226 |
| 2018 | 0 | — | 1 | 1,819 |
| 2019 | 3 | 58 | 0 | 1,593 |
| 2020 | 3 | 64 | 0 | 1,100 |
| 2021 | 1 | — | 0 | 832 |
| 2022 | 0 | — | 0 | 628 |
| 2023 | 1 | — | 0 | 828 |
| 2024 | 0 | — | 0 | 975 |
| 2025 | 0 | — | 0 | 1,105 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medtronic Model 9525 Reveal™ Insertable Loop Recorder is an implantable, patient-activated monitoring system that records subcutaneous ECG and is indicated for patients who experience transient symptoms that may suggest a cardiac arrhythmia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972242: Reveal Insertable Loop Recorder (Ilr) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972242
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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