RX-1 Rhythm Express Remote Cardiac Monitoring System

K200833

VivaQuant Inc. · cleared 2020-09-02 · product code MLO · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology.”
Algorithmembedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology
source quote (p.5)
“An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“ANSI/AAMI TIR57:2015, Principles for medical device security—Risk management”

Validation studies (1)

Bench

sample size not stated

endpoints: continuously record ECG signal; store ECG data in the device memory; transmit manual or auto activated event recordings to the server via mobile network connection for evaluation by a medical professional; all requirements were met and that the RX-1 Monitor performs as designed

standards: IEC 60601-2-47:2012, IEC 60601-1-1:2012 Ed. 3.1, IEC 62304:2015 Ed. 1.1, IEC 60601-1-2:2014 4th Edition, IEC 60601-1-11:2015 Edition 1.1, ANSI/AAMI TIR57:2015, IEC 62366-1:2015 Edition 1.0, ANSI IEEE C63.27-2017, ISO 10993-1

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

2
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
+80%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code MLO (Baxter Healthcare Corporation, initiated 2024-10-11): "There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95559

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/K200833