Product code DSI: 510(k) clearances and predicates
Product code DSI covers BodyGuardian Remote Monitoring System (BGRMS v3.0). FDA lists 398 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
398 clearances on file under product code DSI. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 so far | 1 |
Recent clearances
Newest DSI clearances in the FDA index, with applicant and decision date:
- K243349, BodyGuardian Remote Monitoring System (BGRMS v3.0), applicant Boston Scientific Cardiac Diagnostic Technologies, Inc., decided 2026-01-23. FDA record
- K250356, MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000), applicant Infobionic, Inc., decided 2025-07-29. FDA record
- K240177, Zio AT® device (A100A1001), applicant iRhythm Technologies, Inc., decided 2024-10-30. FDA record
- K230265, MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System, applicant Infobionic, Inc., decided 2023-10-06. FDA record
- K231276, SmartCardia 7L Platform, applicant Smartcardia SA, decided 2023-08-30. FDA record
- K193104, Unified Arrhythmia Diagnostic System PocketECG IV, applicant Medicalgorithmics S.A., decided 2020-04-09. FDA record
- K192732, BodyGuardian Remote Monitoring System, applicant Preventice Technologies, Inc., decided 2020-03-26. FDA record
- K190574, Patient Assistant Model PA97000, applicant Medtronic, Inc., decided 2019-09-24. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000), Zio AT® device (A100A1001). Watch new DSI clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DSI?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DSI clearances include BodyGuardian Remote Monitoring System (BGRMS v3.0).
How many 510(k) clearances use product code DSI?
398 at the time this page was generated, from openFDA records.
How do I find a predicate device under DSI?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DSI clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.