510(k) · Cleared
ClearedSleuth Implantable Ecg Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transnoma Medical, Inc. · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cleared on Oct 1, 2007 as substantially equivalent to K003667 (Medtronic Vascular, 2001) and 3 other predicates after a 367-day review. Its family tree reaches back 4 generations to 1987. 3 later devices descend from it.
- Decided
- Oct 1, 2007
- Review
- 367 days
- Class
- Class II
- Product code
- MXC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K871344 (1987). 14 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- 3 generations backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
- 2 generations backK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- 1 generation backK031466 Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003
- This deviceK063035 Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK073147 Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007
- Descendant · cites it directly · 1 of its ownK083828 Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM…Transoma · 2009
- Descendant · 2 generations on · 0 of its ownK091206 Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna…Transoma Medical · 2009
Most influential descendants
Showing 3 of 3 · See all- K073147Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007 · cites it directly2descendants
- K083828Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Transoma · 2009 · cites it directly1descendant
- K091206Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic…Transoma Medical · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| −3 | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | 1 |
| −2 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| −1 | K031466 | Iqmark Digital Holter | Brentwood Medical Technology Corp. | 2003 | — |
| 0 (this device) | K063035 | Sleuth Implantable Ecg Monitoring System | Transnoma Medical, Inc. | 2007 | — |
| +1 | K073147 | Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08 | Transoma Medical | 2007 | — |
| +1 | K083828 | Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna… | Transoma | 2009 | — |
| +2 | K091206 | Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal… | Transoma Medical | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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? (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 |
|---|---|---|---|
| * | K003667 | Reveal Plus Insertable Loop RecorderSummary page 1…Class II Legally Marketed Device(s) to Medtronic, Inc., Reveal"' Plus Insertable Which Substantial Equivalence Loop Recorder (ILR) System (K003667. is Claimed K994331 and K972242) Brentwood Medica… | 2001 |
| * | K994331 | Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder and Model…Summary page 1…Medtronic, Inc., Reveal"' Plus Insertable Which Substantial Equivalence Loop Recorder (ILR) System (K003667. is Claimed K994331 and K972242) Brentwood Medical Technology Corporation… | 2000 |
| * | K972242 | Reveal Insertable Loop Recorder (Ilr) SystemSummary page 1…Inc., Reveal"' Plus Insertable Which Substantial Equivalence Loop Recorder (ILR) System (K003667. is Claimed K994331 and K972242) Brentwood Medical Technology Corporation… | 1998 |
| * | K031466 | Iqmark Digital HolterSummary page 2…th product specifications. Additionally, testing demonstrated the Sleuth System functions equivalently to comparative systems, i.e., the Brentwood lQmark Digital Holter (K031466) and the Medtronic Reveal Plus Insertable Loop Recorder (K003667, K994331 and K972242). These data support a dete… | 2003 |
What descends from it? (3)
2 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 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K073147 (Transoma Medical, 2007) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K003667.
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. 2007, this device’s year, is highlighted.
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 Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for:
* Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
* Patients who experience transient symptoms that may suggest a cardiac arrhythmia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063035 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063035: Sleuth Implantable Ecg Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063035
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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