510(k) · Cleared
ClearedReveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on May 4, 2011 as substantially equivalent to K071641 (Medtronic, Inc., 2007) and 3 other predicates after a 132-day review. Its family tree reaches back 8 generations to 1987. 26 later devices descend from it.
- Decided
- May 4, 2011
- Review
- 132 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K864889 (1987). 56 ancestors in all, the oldest K832113 (1983). 26 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 7 generations backK950264 MaglifeOdam · 1996
- 6 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 5 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 4 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 3 generations backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- 2 generations backK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- 1 generation backK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- This deviceK103764 Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX…Medtronic, Inc. · 2011
- Descendant · cites it directly · 23 of its ownK132649 Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 15 of its ownK150614 Reveal LINQMedtronic, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK160809 Reveal LINQMedtronic, Inc. · 2016
- Descendant · 4 generations on · 11 of its ownK162855 Reveal LINQMedtronic, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 9 of its ownK200795 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device…Medtronic, Inc. · 2020 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · cites it directly23descendants
- K150614Reveal LINQMedtronic, Inc. · 2015 · 2 generations on15descendants
- K160809Reveal LINQMedtronic, Inc. · 2016 · 3 generations on12descendants
- K162855Reveal LINQMedtronic, Inc. · 2017 · 4 generations on11descendants
- K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library…Medtronic, Inc. · 2020 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −7 | K950264 | Maglife | Odam | 1996 | — |
| −6 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −5 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −4 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −3 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| −2 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| −1 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| 0 (this device) | K103764 | Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable… | Medtronic, Inc. | 2011 | — |
| +1 | K132649 | Reveal Linq Insertable Cardiac Monitor | Medtronic, Inc. | 2014 | 1 |
| +2 | K150614 | Reveal LINQ | Medtronic, Inc. | 2015 | — |
| +3 | K160809 | Reveal LINQ | Medtronic, Inc. | 2016 | — |
| +4 | K162855 | Reveal LINQ | Medtronic, Inc. | 2017 | 1 |
| +5 | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command… | Medtronic, Inc. | 2020 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Summary page 1…substantially equivalent to the following predicate devices: * Medtronic Reveal XT Model 9529 Insertable Cardiac Monitor (1CM) originally cleared via 5 10(k) reference K071641 and the Reveal DX Model 9528 Insertable Cardiac Monitor originally cleared via 5 10(k) reference K07 1655 on November 21, 2007… | 2007 |
| * | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Summary page 1…rdiac Monitor (1CM) originally cleared via 5 10(k) reference K071641 and the Reveal DX Model 9528 Insertable Cardiac Monitor originally cleared via 5 10(k) reference K07 1655 on November 21, 2007 (including patient assistants). The Reveal XT Model 9529 and Reveal DX Model 9528 enhancements previousl… | 2007 |
| * | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Summary page 1…K07 1655 on November 21, 2007 (including patient assistants). The Reveal XT Model 9529 and Reveal DX Model 9528 enhancements previously cleared via 5 10(k) reference K082475 on November 7, 2008 (including patient assistants). * Instromedix King of Hearts Express AF Recorder - K020825, Cleared April 5… | 2008 |
| * | K020825 | King of Hearts Express + AF MonitorSummary page 1…enhancements previously cleared via 5 10(k) reference K082475 on November 7, 2008 (including patient assistants). * Instromedix King of Hearts Express AF Recorder - K020825, Cleared April 5,2002 Device Description The Reveal XT Model 9529 and Reveal DX Model 9528 Insertable Cardiac Monitors (1CM) ar… | 2002 |
What descends from it? (26)
See all 262 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 56 ancestors have a recall of any class.
- Of its descendants, K132649 (Medtronic, Inc., 2014) has gone furthest, with 23 descendants of its own.
- 5 other devices also cite its predicate K071641.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Reveal XTIDX 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 Reveal XT/DX Patient…
Read the full statement (131 words)
The Reveal XTIDX 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 Reveal XT/DX Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:
* To verify whether the implanted device has detected a suspected arrhythmia or device related event. *
* To initiate recording of cardiac event data in the implanted device memory.
*only applicable to the Reveal XTPatientAssistant Model 9S39
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103764 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103764
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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