BodyGuardian Remote Monitoring System

K192732

Preventice Technologies, Inc. · cleared 2020-03-26 · product code DSI · Cardiovascular

Premarket evidence — what FDA accepted

Device typesimd
source quote (p.3)
“The BodyGuardian System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional.”
AlgorithmFDA source did not state this
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: EMC and electrical safety testing; Electrical and mechanical safety testing; System safety testing; Software verification and validation; Performance testing; Predicate device comparison tests; Usability Testing; Biocompatibility for patient contact materials

standards: ISO 60601 Testing, Edition 3.1.

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

21
recalls in product code, 24mo
373
MAUDE reports in code, 12mo
-74%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DSI (GE Medical Systems Information Technologies Inc, initiated 2025-04-25): "The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially mani" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96830

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K192732