Peerbridge Cor(TM) System

K171936

Peerbridge Health INc. · cleared 2017-09-27 · product code DSH · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.3)
“The Peerbridge Cor™ System contains a continuous external electrocardiogram (ECG) recorder with a patient-activated events button. It is indicated for use on adult patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, pre-syncope, fatigue, or anxiety. The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms. The report generated does not contain diagnostic interpretation; the report is provided for review by intended users to render a diagnosis based on their clinical judgment and experience.”
AlgorithmFDA cleared algorithms for 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis
source quote (p.3)
“The reported ECG metrics supports 2-channel ECG analysis on a beat-by-beat basis, heart rate measurement and rhythm analysis by FDA cleared algorithms.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Software unit, integration, and system level testing; Biocompatibility; Electrical Safety and Electromagnetic Compatibility testing; Defibrillation Safety testing; ECG Wearable Sensor functional testing; Wearability testing; Summative human factors and usability testing

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

0
recalls in product code, 24mo
288
MAUDE reports in code, 12mo
+253%
vs code's own 3-yr baseline
1
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code DSH: 288 in the 12 months ending 2026-06, vs a 81.7/12mo average over the prior 3 windows (+253%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=DSH

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/K171936