Cleared Traditional

K213971 - Atrial Fibrillation History Feature

K213971 is an FDA 510(k) clearance for Atrial Fibrillation History Feature, manufactured by Apple, Inc.. The device is a Class 2 Cardiovascular device with product code QDB cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K213971 · Apple, Inc. · Cardiovascular device
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Jun 2022
Decision
165d
Days
Class 2
Risk

K213971 is an FDA 510(k) clearance for the Atrial Fibrillation History Feature. Classified as Photoplethysmograph Analysis Software For Over-the-counter Use (product code QDB), Class II - Special Controls.

Submitted by Apple, Inc. (Cupertino, US). The FDA issued a Cleared decision on June 3, 2022 after a review of 165 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2790 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K213971

510(k) Number K213971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2021
Decision Date June 03, 2022
Days to Decision 165 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 125d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QDB Device Classification - Class 2, Special Controls

Product Code QDB Photoplethysmograph Analysis Software For Over-the-counter Use
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.