510(k) · Cleared
ClearedBodyguardian System Bodyguardian Control Unit Bodyguardian Connect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preventice, Inc. · DSI Detector And Alarm, Arrhythmia
Cleared on Aug 10, 2012 as substantially equivalent to K083287 (Corventis, Inc., 2009) after a 113-day review. Its family tree reaches back 6 generations to 1988. 10 later devices descend from it.
- Decided
- Aug 10, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K882803 (1988). 11 ancestors in all. 10 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 5 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 4 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 3 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 2 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 1 generation backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- This deviceK121197 Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectPreventice, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK193296 eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK222842 V-Patch Cardiac MonitorShandong Corecare Technology Limited · 2022
- Descendant · cites it directly · 1 of its ownK162956 Nowcardio SystemContex International Technologies (Canada), Inc. · 2017
- Descendant · cites it directly · 1 of its ownK133753 Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK132447 Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K193296eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc. · 2020 · cites it directly3descendants
- K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited · 2022 · 2 generations on1descendant
- K162956Nowcardio SystemContex International Technologies (Canada), Inc. · 2017 · cites it directly1descendant
- K133753Mome Ecg Continuous Detection and Arrhythmia DetectorInfobionic, Inc. · 2014 · cites it directly1descendant
- K132447Vitalconnect Platform by Vital Connect Inc.Vitalconnect, Inc. · 2014 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −5 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −4 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −3 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −2 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −1 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| 0 (this device) | K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect | Preventice, Inc. | 2012 | — |
| +1 | K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | 2020 | — |
| +2 | K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | 2022 | — |
| +1 | K162956 | Nowcardio System | Contex International Technologies (Canada), Inc. | 2017 | — |
| +1 | K133753 | Mome Ecg Continuous Detection and Arrhythmia Detector | Infobionic, Inc. | 2014 | — |
| +1 | K132447 | Vitalconnect Platform by Vital Connect Inc. | Vitalconnect, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K083287 | Avivo Mobile Patient Management SystemSummary page 1…rhythmia detection) * Arrhythmia Detector and Alarm Product Codes: MHX, DSI Predicate Device: AVIVO Mobile Patient Management System (k083287) Device Description: The BodyGuardian System is an ambulatory cardiac monitoring system prescribed by hea… | 2009 |
What descends from it? (10)
4 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K193296 (Ecordum, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K083287.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 non-lethal cardiac arrhythmias in
ambulatory patients, when prescribed by a physician or other qualified healthcare
professional. The BodyGuardian System continuously records, stores and periodically
transmits the following physiological data to a remote computer server for up to 30 days
at a time:
*ECG
*Heart rate (including HIR variability and HR reliability)
*Respiration rate
*Activity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121197: Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121197
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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