AT-Patch (ATP-C130/ATP-C70)

K242583

ATsens Co.,Ltd. · cleared 2025-05-02 · product code DSH · Cardiovascular

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“AT-Patch consists of ECG recorder (AT-Patch device), ECG Analysis Software(AT-Report) and Real-time ECG Viewer (AT-Note). ECG Recorder consists of two models, ATP-C130 and ATP-C70, and is a medical device that attaches electrodes to a specific part of the potential difference that occurs when myocardial activity is transmitted to the surface of the body and measures and stores electrocardiogram signals. ... AT-Report is a medical device software that receives data stored in AT-Patch device using a Dedicated USB Cable and analyses it to provide information which is used to take decisions with diagnosis and can confirm the operation of AT-Patch device using the BLE communication function. ... The AT-Report software utilizes machine learning-based algorithms to automatically detect and classify arrhythmia events from ECG data recorded by the AT-Patch device.”
Algorithmmachine learning-based algorithms
source quote (p.15)
“The AT-Report software utilizes machine learning-based algorithms to automatically detect and classify arrhythmia events from ECG data recorded by the AT-Patch device.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.18)
“Cybersecurity tests were performed in accordance the FDA recognized guidance. - Cybersecurity in medical devices: quality system considerations and content of premarket submissions. - FDA Act 524B”

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: accuracy of QRS detection; VEB/SVEB detection; atrial fibrillation (AF) detection; Couplets; Runs; Tachycardia detection; Sensitivity; Positive Predictive Value (PPV); False Positive Rate (FPR)

standards: ANSI/AAMI EC57:2012

Reported performance (1 observation)

ppvas written: “Positive Predictive Value (PPV)”stated without value
source quote (p.19)
“Performance was assessed based on Sensitivity, Positive Predictive Value (PPV), and False Positive Rate (FPR), validated against reference data.”

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/K242583