RX-1 Rhythm Express Remote Cardiac Monitoring System

K183704

VivaQuant Inc. · cleared 2019-02-16 · product code DXH · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology.”
Algorithmembedded ECG analysis algorithm to auto-capture Bradycardia, Tachycardia, Atrial Fibrillation/Atrial Flutter and arrhythmia events
source quote (p.9)
“Device incorporate embedded ECG analysis algorithm to auto-capture Bradycardia, Tachycardia, Atrial Fibrillation/Atrial Flutter and arrhythmia events between the signal acquisition point and the server.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.10)
“ANSI/AAMI TIR57:2015, Principles for medical device security— Risk management”

Validation studies (1)

Bench

sample size not stated

standards: IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems., IEC 60601-1-2:2014 4th Edition, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility – Requirements and tests., IEC 60601-1-11:2015 Edition 1.1, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment., ANSI/AAMI TIR57:2015, Principles for medical device security— Risk management, IEC 62366-1:2015 Edition 1.0, Medical devices – Part 1: Application of usability engineering to medical devices, ANSI IEEE C63.27-2017 Evaluation of Wireless Coexistence, Biocompatibility testing of patient contacting materials according to 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

1
recalls in product code, 24mo
28
MAUDE reports in code, 12mo
+950%
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K200833 (decision 2020-09-02) from VivaQuant Inc. for a matching device line ("RX-1 Rhythm Express Remote Cardiac Monitoring System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K200833

  • adverse_event_inflection

    MAUDE adverse-event reports for product code DXH: 28 in the 12 months ending 2026-06, vs a 2.7/12mo average over the prior 3 windows (+950%). 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=DXH

  • recall_reason_pattern

    Software/algorithm-related recall in product code DXH (GE Medical Systems China Co., Ltd. No. 19 Changjiang Road Development Zone National Hi-Tech Xin District Wuxi China, initiated 2026-04-21): "Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98917

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/K183704