510(k) · Cleared
ClearedBodyGuardian Remote Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preventice Technologies, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Mar 26, 2020 as substantially equivalent to K151188 (Preventice, 2015) after a 181-day review. Its family tree reaches back 1 generation to 2015. 1 later device descends from it.
- Decided
- Mar 26, 2020
- Review
- 181 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K151188 (2015). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK151188 BodyGuardian Remote Monitoring SystemPreventice · 2015 · Recalled
- This deviceK192732 BodyGuardian Remote Monitoring SystemPreventice Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK243349 BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K151188 | BodyGuardian Remote Monitoring System | Preventice | 2015 | 1 |
| 0 (this device) | K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | 2020 | — |
| +1 | K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K151188 | BodyGuardian Remote Monitoring SystemSummary page 4…Rochester, MN 55122 Establishment Registration: 3009883402 Predicate Device: BodyGuardian Remote Monitoring System, K151188 Device Description: Arrhythmia Detector and Alarm; Patient Physi… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | 2026 | 0 |
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?
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional. Not for use with patients requiring attended, in-hospital monitoring for life threatening arrhythmias. The Preventice BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients in clinical and non-clinical settings to collect and transmit health parameters to…
Read the full statement (120 words)
The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients,
when prescribed by a physician or other qualified healthcare professional. Not for use with
patients requiring attended, in-hospital monitoring for life threatening arrhythmias.
The Preventice BodyGuardian Remote Monitoring System is intended for use with adult and
pediatric patients in clinical and non-clinical settings to collect and transmit health parameters
to healthcare professionals for monitoring and evaluation. Health parameters are collected from
a variety of commercially available, external plug in devices such as ECG sensors, weight
scales, blood pressure meters and pulse oximeters, and parameters such as ECG, heart rate,
body weight, temperature, respiration rate, blood pressure, and SpO2.
The Preventice BodyGuardian Remote Monitoring System does not provide any diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192732 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192732: BodyGuardian Remote Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192732
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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