510(k) · Cleared
Recalled · Class II · 2016Telesentry, Model TS01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scottcare Corporation · DSI Detector And Alarm, Arrhythmia
Cleared on Feb 26, 2010 as substantially equivalent to K081444 (Braemar, Inc., 2008) after a 155-day review. Its family tree reaches back 1 generation to 2008. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 26, 2010
- Review
- 155 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081444 (2008). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK081444 Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring SystemBraemar, Inc. · 2008
- This deviceK092947 Telesentry, Model TS01Scottcare Corporation · 2010
- Descendant · cites it directly · 0 of its ownK153477 EMMa Electronic Monitoring ManagementVitasystems GmbH · 2016
- Descendant · cites it directly · 0 of its ownK152973 Dyna-Vision Telemonitoring SystemTechmedic Development International B.V. · 2016
- Descendant · cites it directly · 0 of its ownK142180 TelesenseScottcare Corporation · 2014
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K081444 | Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System | Braemar, Inc. | 2008 | — |
| 0 (this device) | K092947 | Telesentry, Model TS01 | Scottcare Corporation | 2010 | — |
| +1 | K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | 2016 | — |
| +1 | K152973 | Dyna-Vision Telemonitoring System | Techmedic Development International B.V. | 2016 | — |
| +1 | K142180 | Telesense | Scottcare Corporation | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 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? (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 |
|---|---|---|---|
| * | K081444 | Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring SystemSummary page 1…roduct Code: DRG Legally Marketed Predicate Device(s): Braemar Fusion Wireless - Ambulatory ECG Arrhythmia Monitoring System (K08 1444), July 31, 2008 A Scott Fetzer, Berkshire Hathaway Companly… | 2008 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2016 | Class II | Z-1315-2016 | Device Design | The firm received a complaint of the battery exploding while recharging. |
| Jan 19, 2012 | Not classified | Z-1400-2012 | Component design/selection | Certain TeleSentry Devices contain a Bad SD Card. When the SD Card goes bad, the TeleSentry Device cannot read or write data to the SD Card. The TeleSentry Device then stops functioning. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomnatic events that may suggest non-lethal cardiac arrhythmria. The device continuously monitors and records the data, automatically records alarm events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092947: Telesentry, Model TS01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092947
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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