510(k) · Cleared
ClearedSleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic Manager (PDM) Accessory Kit, Model
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transoma Medical · MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Cleared on May 18, 2009 as substantially equivalent to K083828 (Transoma, 2009) after a 24-day review. Its family tree reaches back 7 generations to 1987.
- Decided
- May 18, 2009
- Review
- 24 days
- Class
- Class II
- Product code
- MXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K871344 (1987). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- 6 generations backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
- 5 generations backK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- 4 generations backK031466 Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003
- 3 generations backK063035 Sleuth Implantable Ecg Monitoring SystemTransnoma Medical, Inc. · 2007
- 2 generations backK073147 Sleuth Implantable Ecg System-8 CM Accessory Kit, Model 3000-08Transoma Medical · 2007
- 1 generation backK083828 Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM…Transoma · 2009
- This deviceK091206 Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna…Transoma Medical · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| −6 | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | 1 |
| −5 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| −4 | K031466 | Iqmark Digital Holter | Brentwood Medical Technology Corp. | 2003 | — |
| −3 | 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 | — |
| −1 | K083828 | Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna… | Transoma | 2009 | — |
| 0 (this device) | 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 |
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 9.5 · 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? (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 |
|---|---|---|---|
| * | K083828 | Sleuth at Implantable Cardiac Monitoring System -6 CM and 8CM Antenna, Personal…Summary page 1…I Legally Marketed Device to Which Substantial Equivalence Sleuth AT Implantable Cardiac Monitoring is Claimed: System (K083828) 2 Device Description The Sleuth AT Implantable Cardiac System is an electrocardiogram (ECU) monitoring system that… | 2009 |
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 22 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
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. 2009, 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 Sleuth AT system is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECU 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/K091206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091206: Sleuth at Implantable Cardiac Monitoring System-6 and 8CM Antenna, Personal Diagnostic Manager (PDM) Accessory Kit, Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091206
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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