Cleared Traditional

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

K242583 · Atsens Co., Ltd. · Cardiovascular

May 2025

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K242583 is an FDA 510(k) clearance for the AT-Patch (ATP-C130/ATP-C70), a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Atsens Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on May 2, 2025, 245 days after receiving the submission on August 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K242583 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 30, 2024
Decision Date	May 02, 2025
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF