Cleared Traditional

K212516 - IRNF App (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence.

K212516 · Apple, Inc. · Cardiovascular device
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Oct 2021
Decision
73d
Days
Class 2
Risk

K212516 is an FDA 510(k) clearance for the IRNF App. 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 October 22, 2021 after a review of 73 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Apple, Inc. devices

Submission Details

510(k) Number K212516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2021
Decision Date October 22, 2021
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04699812 Completed Interventional Industry-sponsored

Atrial Fibrillation Algorithms Clinical Validation Study

573
Patients (actual)
4
Sites
Screening
Purpose
Open label
Masking
Condition studied Atrial Fibrillation
Study design Parallel
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator David Tsay, MD, PhD
Sponsor Apple Inc. (industry)
Started 2020-11-16 → Primary completion 2021-04-19 → Completed 2021-12-17
Primary outcome
SENSITIVITY OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
Secondary outcome
POSITIVE PREDICTIVE VALUE OF IRREGULAR RHYTHM NOTIFICATION FEATURE [IRNF]
View full study on ClinicalTrials.gov