510(k) · Cleared
ClearedBraemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Braemar, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Jul 31, 2008 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 31, 2008
- Review
- 70 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK081444 Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring SystemBraemar, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK092947 Telesentry, Model TS01Scottcare Corporation · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK153477 EMMa Electronic Monitoring ManagementVitasystems GmbH · 2016
- Descendant · 2 generations on · 0 of its ownK152973 Dyna-Vision Telemonitoring SystemTechmedic Development International B.V. · 2016
- Descendant · 2 generations on · 0 of its ownK142180 TelesenseScottcare Corporation · 2014
- Descendant · cites it directly · 0 of its ownK111160 Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System…Intricon Datrix Corporation · 2011
Most influential descendants
Showing 5 of 5 · See all- K092947Telesentry, Model TS01Scottcare Corporation · 2010 · cites it directly3descendants
- K153477EMMa Electronic Monitoring ManagementVitasystems GmbH · 2016 · 2 generations on0descendants
- K152973Dyna-Vision Telemonitoring SystemTechmedic Development International B.V. · 2016 · 2 generations on0descendants
- K142180TelesenseScottcare Corporation · 2014 · 2 generations on0descendants
- K111160Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets)Intricon Datrix Corporation · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081444 | Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System | Braemar, Inc. | 2008 | — |
| +1 | K092947 | Telesentry, Model TS01 | Scottcare Corporation | 2010 | 2 |
| +2 | K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | 2016 | — |
| +2 | K152973 | Dyna-Vision Telemonitoring System | Techmedic Development International B.V. | 2016 | — |
| +2 | K142180 | Telesense | Scottcare Corporation | 2014 | — |
| +1 | K111160 | Intricon Datrix Centauri MT Ambulatory Patient Ecg Telemetry System (Apets) | Intricon Datrix Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
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?
- Of its descendants, K092947 (Scottcare Corporation, 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 device is intended for diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors, automatically generates an alarm 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 510(k) statement.
https://510kreport.com/device/K081444 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081444: Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia 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/K081444
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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