510(k) · Cleared
ClearedIntricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intricon Datrix Corporation · DSI Detector And Alarm, Arrhythmia
Cleared on Aug 1, 2011 as substantially equivalent to K081444 (Braemar, Inc., 2008) and 1 other predicate after a 98-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Aug 1, 2011
- Review
- 98 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923930 (1992). 5 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
- 2 generations backK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
- 1 generation backK042022 E-Tac EX-1000 Electrocardiographic Event RecorderDatrix, Inc. Dba of Jon Barron, Inc. · 2004
- This deviceK111160 Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System…Intricon Datrix Corporation · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| −2 | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 | Braemar Corp. | 1998 | — |
| −1 | K042022 | E-Tac EX-1000 Electrocardiographic Event Recorder | Datrix, Inc. Dba of Jon Barron, Inc. | 2004 | — |
| 0 (this device) | K111160 | Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets) | Intricon Datrix Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K081444 | Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring SystemSummary page 2…ver-chloride electrodes appropriate for long-term recording. Predicate Device: Braemar, Inc. Fusion Wireless Recorder (K081444), Datrix E-Tac EX- 1000 Electrocardiographic Event Recorder (K0… | 2008 |
| * | K042022 | E-Tac EX-1000 Electrocardiographic Event RecorderSummary page 2…ar, Inc. Fusion Wireless Recorder (K081444), Datrix E-Tac EX- 1000 Electrocardiographic Event Recorder (K042022) Substantial Equivalence: Comparison to the predicate devices listed shows nearly ide… | 2004 |
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 19 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K081444.
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 IntriCon Datrix Centauri MT Ambulatory Patient ECG Telemetry System (APETS) is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an event triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded cardiac activity associated with these symptoms for review by a licensed physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111160: Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111160
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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