510(k) · Cleared
ClearedReveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538
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 Nov 21, 2007 as substantially equivalent to K994331 (Medtronic Vascular, 2000) and 4 other predicates after a 156-day review. Its family tree reaches back 6 generations to 1987. 30 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 156 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K864889 (1987). 53 ancestors in all, the oldest K832113 (1983). 30 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK864889 Omni-TrakInvivo Research Labs, Inc. · 1987
- 5 generations backK950264 MaglifeOdam · 1996
- 4 generations backK023195 Maglife C/Maglife C PlusSchiller Medical S.A. · 2003
- 3 generations backK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
- 2 generations backK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
- 1 generation backK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
- This deviceK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
- Descendant · cites it directly · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008
- Descendant · cites it directly · 26 of its ownK103764 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
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · cites it directly28descendants
- K103764Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac…Medtronic, Inc. · 2011 · cites it directly26descendants
- K132649Reveal Linq Insertable Cardiac MonitorMedtronic, Inc. · 2014 · cites it directly23descendants
- K150614Reveal LINQMedtronic, Inc. · 2015 · 2 generations on15descendants
- K160809Reveal LINQMedtronic, Inc. · 2016 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864889 | Omni-Trak | Invivo Research Labs, Inc. | 1987 | — |
| −5 | K950264 | Maglife | Odam | 1996 | — |
| −4 | K023195 | Maglife C/Maglife C Plus | Schiller Medical S.A. | 2003 | — |
| −3 | K040915 | Magnitude 3150M Mri Patient Monitor, Model 3150M | Invivo Research, Inc. | 2004 | — |
| −2 | K050399 | Mri Compatible Patient Monitoring System, Model 3160 | Invivo Research, Inc. | 2005 | — |
| −1 | K053462 | 3160 Mri Patient Monitoring System | Invivo Corporation | 2006 | 2 |
| 0 (this device) | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
| +1 | K082475 | Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac… | Medtronic, Inc. | 2008 | — |
| +1 | 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 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K994331 | Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model…Summary page 1…Monitor (Model 9528) are substantial1y CleUivalent to the following predicate devices: * Medtronic Reveal Plus (Model 9:526) ILR - K994331. Cleared 21 January 2000/K003667, Cleared 14 February 200 1 • Novacor Vista Plus Holter… | 2000 |
| * | K003667 | Reveal Plus Insertable Loop RecorderSummary page 1…the following predicate devices: * Medtronic Reveal Plus (Model 9:526) ILR - K994331. Cleared 21 January 2000/K003667, Cleared 14 February 200 1 • Novacor Vista Plus Holter Recorder - K042 108, Cleared 19 January 2005… | 2001 |
| * | K042108 | Vista PlusSummary page 1…s (Model 9:526) ILR - K994331. Cleared 21 January 2000/K003667, Cleared 14 February 200 1 • Novacor Vista Plus Holter Recorder - K042 108, Cleared 19 January 2005 * IM Systems Actitrac Activity Monitor - K992410, Cleared 15 October 1999… | 2005 |
| * | K992410 | ActitracSummary page 1…February 200 1 • Novacor Vista Plus Holter Recorder - K042 108, Cleared 19 January 2005 * IM Systems Actitrac Activity Monitor - K992410, Cleared 15 October 1999 * Invivo Corporation Model 3160 MRI Patient Monitor (MRI compatible… | 1999 |
| * | K053462 | 3160 Mri Patient Monitoring SystemSummary page 1…Cleared 15 October 1999 * Invivo Corporation Model 3160 MRI Patient Monitor (MRI compatible muiltiparameter patient monitor) - 1K053462, Cleared 18 January 2005 The intended use, design, materials and perlormancc of the Reveal Patient… | 2006 |
What descends from it? (30)
See all 304 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 20 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 53 ancestors have a recall of any class.
- Of its descendants, K082475 (Medtronic, Inc., 2008) has gone furthest, with 28 descendants of its own.
- 3 other devices also cite its predicate K994331.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 DX 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 that may suggest a cardiac arrhythmia The Reveal Patient Assistant is intended for unsupervised patient use away from a hospital…
Read the full statement (122 words)
The Reveal DX 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 that may suggest a cardiac arrhythmia
The Reveal 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 XT PatientAssistant Model 9539
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071655
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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