Cleared Traditional

Zio? monitor (DFG0001)

K243650 · iRhythm Technologies, Inc. · Cardiovascular

Aug 2025

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K243650 is an FDA 510(k) clearance for the Zio? monitor (DFG0001), a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 15, 2025, 262 days after receiving the submission on November 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K243650 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 2024
Decision Date	August 15, 2025
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF