510(k) · Cleared
ClearedIntricon Datrix Sirona Event/ Holter Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intricon Datrix Corporation · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Nov 9, 2011 as substantially equivalent to K071011 (Braemar, Inc., 2007) and 2 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Nov 9, 2011
- Review
- 63 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K921068 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK921068 Gikter Ecg Cassette Tape Recorder Model XR 300Datrix · 1992
- 2 generations backK982975 Digital Ecg Holter Recorder, Model DR512Datrix · 1998
- 1 generation backK031074 Digital Ambulatory Ecg (Holter) RecorderDatrix · 2003
- This deviceK112601 Intricon Datrix Sirona Event/ Holter RecorderIntricon Datrix Corporation · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921068 | Gikter Ecg Cassette Tape Recorder Model XR 300 | Datrix | 1992 | — |
| −2 | K982975 | Digital Ecg Holter Recorder, Model DR512 | Datrix | 1998 | — |
| −1 | K031074 | Digital Ambulatory Ecg (Holter) Recorder | Datrix | 2003 | — |
| 0 (this device) | K112601 | Intricon Datrix Sirona Event/ Holter Recorder | Intricon Datrix Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K071011 | Modification to: Braemar ER900 Series Enhanced Algorithm Ecg Event RecorderSummary page 1…operate in one of three modes depending on clinician selected options. Predicate Device: Braemar Er900 (K07101 11K072008), Datrix VX3 (K031074). Iritrcon Matix Sirona Trad… | 2007 |
| * | K072008 | Braemar ER900 Wireless Series Arrhythmia Event RecorderSummary page 1…ate in one of three modes depending on clinician selected options. Predicate Device: Braemar Er900 (K07101 11K072008), Datrix VX3 (K031074). Iritrcon Matix Sirona Traditional… | 2007 |
| * | K031074 | Digital Ambulatory Ecg (Holter) RecorderSummary page 1…clinician selected options. Predicate Device: Braemar Er900 (K07101 11K072008), Datrix VX3 (K031074). Iritrcon Matix Sirona Traditional 510(k) 16 of 589… | 2003 |
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 2 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The IntriCon Datrix Sirona is a combination Event Recorder and Holter Recorder that is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. In the Event Recorder mode, once event data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician. In the Holter Recorder mode, the device is intended for the recording of ECG data collected from ambulatory patients. The data is then reviewed by the physician after downloading and processing by a Holter playback system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112601 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112601: Intricon Datrix Sirona Event/ Holter Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112601
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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