BodyGuardian Remote Monitoring System (BGRMS v3.0)

510(k) premarket notification. Decision: Substantially Equivalent, 23 January 2026. Product code DSI.

Clearance

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
510(k) number	K243349	k_number
Device name	BodyGuardian Remote Monitoring System (BGRMS v3.0)	device_name
Applicant	Boston Scientific Cardiac Diagnostic Technologies, Inc.	applicant
Decision date	2026-01-23	decision_date
Decision	Substantially Equivalent	decision
Product code	DSI	product_code
Device class	null	device_class
Review panel	Cardiovascular	review_panel
Clearance type	Traditional	clearance_type
Statement or summary	Summary	summary_type
Regulation number	null	regulation_number
Predicate devices	null	predicate_devices

Source: FDA openFDA, device/510k, K243349, retrieved 2026-09-19 21:50 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

DSI

Detector And Alarm, Arrhythmia

Device class 2 · Regulation 870.1025 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

DSI is one of the 56 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

Resolved to

Boston Scientific

The register name above is resolved to its organisation under ArrHub’s alias table. Method: manual. Source: fda_applicant. Verified 20 September 2026.

First seen by ArrHub’s weekly snapshot: 2026-09-23 07:46 Eastern.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/510k.json?search=k_number:K243349&limit=1

{
  "id": "952bf6e6-7e3f-4983-a68a-7437cfb192a9",
  "k_number": "K243349",
  "device_name": "BodyGuardian Remote Monitoring System (BGRMS v3.0)",
  "applicant": "Boston Scientific Cardiac Diagnostic Technologies, Inc.",
  "decision_date": "2026-01-23",
  "decision": "Substantially Equivalent",
  "product_code": "DSI",
  "device_class": null,
  "review_panel": "Cardiovascular",
  "clearance_type": "Traditional",
  "summary_type": "Summary",
  "regulation_number": null,
  "predicate_devices": null,
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243349",
  "verified_at": "2026-09-20T01:51:05.363+00:00",
  "created_at": "2026-09-20T01:50:41.55224+00:00",
  "updated_at": "2026-09-20T01:50:26.884+00:00",
  "collected_at": "2026-09-20T01:50:26.884+00:00",
  "last_checked_at": null
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

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