# K242583: AT-Patch (ATP-C130/ATP-C70)

- Pathway: 510(k) (Traditional)
- Applicant: Atsens Co., Ltd.
- Decided: May 2, 2025 after 245 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930806 (1994). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203638: AT-Patch ECG Analysis System, Atsens Co., Ltd. (2022) Summary page 5.
- K162023: CardioDay V2.5, Getemed Medizin- Und Informationstechnik AG (2017) Summary page 6.

## Indications for use
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.

Source page: https://510kreport.com/device/K242583
Methodology: https://510kreport.com/methodology