Cleared Traditional

Irregular Rhythm Notification Feature (IRNF)

K231173 · Apple, Inc. · Cardiovascular

Jul 2023

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K231173 is an FDA 510(k) clearance for the Irregular Rhythm Notification Feature (IRNF), a Photoplethysmograph Analysis Software For Over-the-counter Use (Class II — Special Controls, product code QDB), submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 21, 2023, 87 days after receiving the submission on April 25, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2790.

Submission Details

510(k) Number	K231173 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 25, 2023
Decision Date	July 21, 2023
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	QDB — Photoplethysmograph Analysis Software For Over-the-counter Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2790
Definition	A Photoplethysmograph Analysis Software Device For Over-the-counter Use Analyzes Photoplethysmograph Data And Provides Information For Identifying Irregular Heart Rhythms. This Device Is Not Intended To Provide A Diagnosis.