Cardiovascular · 510(k) · 2025
AT-Patch (ATP-C130/ATP-C70)
ATsens Co.,Ltd.. Cleared by FDA on 2 May 2025 under submission K242583, product code DSH (recorder, magnetic tape, medical). What FDA's record says, in FDA's words.
Device record · K242583
- Device. AT-Patch (ATP-C130/ATP-C70)DEVICE
- Company. ATsens Co.,Ltd. (KR)COMPANY
- Decision. 2 May 2025, 510(k), substantially equivalent (traditional review); received 30 August 2024DECISION
- Panel. CardiovascularPANEL
- Product code. DSH, Recorder, Magnetic Tape, MedicalCODE
- Regulation. 21 CFR 870.2800, Class IIREG
- Source. FDA database entry · decision document (19 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for long- term recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient’s torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only. The device is used by patients as prescribed by physicians or medical personnel. It is indicated for use on 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, fatigue, or anxiety.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 972 reports filed against devices carrying product code DSH. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
11 September 2026 · Injury · ePatch 2.5, BTH · Braemar Manufacturing, LLC · report 2133409-2026-00193
Alleged burn was initially reported on (b)(6) 2026. Patient was unable to specify whether they believed the issue was caused by the sensor or the patch, but stated the sensor was not hot. Patient was sitting and watching tv at the time of occurrence. Additional information was received on 14 August 2026 via GFE response. Patient was still unable to clarify whether they believed the burn to be from the sensor overheating or the patch. Patient described their symptoms as itchy chemical burns. […]
11 September 2026 · Injury · ePatch 2.5, BTH · Braemar Manufacturing, LLC · report 2133409-2026-00194
On (b)(6) 2026 the patient called to report skin irritation from an ePatch used with Universal Patch configuration (Lot #E651128). The patient described the irritation as a painful raised skin chemical burn, characterized as a severe burn with a hole and discharge. Additional symptoms included burning sensation, itching, rash, bleeding/discharge, open sores, and rawness of the skin. Additional information was received on 17 August 2026 via GFE response. Patient stated they believed the burn […]
4 September 2026 · Injury · CAM System · BARDY DIAGNOSTICS, INC. · report 3014226707-2026-00011
4 September 2026 · Injury · CAM System · BARDY DIAGNOSTICS, INC. · report 3014226707-2026-00010
2 September 2026 · Injury · ePatch 2.5, BTH · Braemar Manufacturing, LLC · report 2133409-2026-00190
On (b)(6) 2026 the patient reported experiencing a rash which they described as a "3rd degree burn" that oozes while wearing the ePatch Sensor - 2.5 utilizing the Electrode - Patch - Universal 2 Channel configuration. The patient's symptoms were categorized as burning sensation, rash, bleeding with discharge, and rawness and open skin. The patient did not seek medical treatment for the skin irritation. The patient confirmed following the recommended skin preparation steps and has no history of […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DSH, in Cardiovascular, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.