510(k) · Cleared
ClearedEMMa Electronic Monitoring Management
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitasystems GmbH · DSI Detector And Alarm, Arrhythmia
Cleared on May 25, 2016 as substantially equivalent to K092947 (Scottcare Corporation, 2010) after a 175-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- May 25, 2016
- Review
- 175 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081444 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K092947 | Telesentry, Model TS01Summary page 5…Page 1 of 5 vitasystems GmbH 510(k) Submission EMMa Sec. 5, 510(k) Summary 1. Legally Marketed Predicate Devices K092947 DSI/DRG Telesentry, Model TS01, Scottcare Corporation 2. Indications & Intended Use The EMMa (Electronic Monitoring M… | 2010 |
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 8 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K092947.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 EMMa system is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia to support and possibly improve an ongoing treatment by the patient’s physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physician for review.…
Read the full statement (101 words)
The EMMa system is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia to support and possibly improve an ongoing treatment by the patient’s physician. Data received from battery powered ambulatory monitoring devices, triggered by an arrhythmia detection algorithm or manually by the patient, are stored and forwarded to licensed physician for review.
Contraindications of Use:
- Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
- Patients who the attending physician thinks should be hospitalized.
The software is not intended to be used to trigger emergency treatment or alert chains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153477: EMMa Electronic Monitoring Management.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153477
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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