BodyGuardian Remote Monitoring System— 510(k) K151188

Name: FDA 510(k) clearance K151188
Creator: U.S. Food and Drug Administration
Published: 2015-09-17

Substantially Equivalent

Preventice

FDA 510(k) clearance K151188 for BodyGuardian Remote Monitoring System, Substantially Equivalent on 2015-09-17. Applicant: Preventice. Device class: 2.

Clearance details

Applicant: Preventice
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2015-05-04
Decision date: 2015-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSI

view all

K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)2026-01-23
K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)2025-07-29
K240177 — Zio AT® device (A100A1001)2024-10-30
K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System2023-10-06
K231276 — SmartCardia 7L Platform2023-08-30

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K151188

K-number listed on FDA's recall record

Z-2479-2020 — BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors.Class II·Terminated·Preventice Services, LLC·20190806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151188.

Data sourced from openFDA. This site is unofficial and independent of the FDA.