Cleared Traditional

K212372 - Fitbit Irregular Rhythm Notifications (FDA 510(k) Clearance)

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

K212372 · Fitbit, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
252d
Days
Class 2
Risk

K212372 is an FDA 510(k) clearance for the Fitbit Irregular Rhythm Notifications. Classified as Photoplethysmograph Analysis Software For Over-the-counter Use (product code QDB), Class II - Special Controls.

Submitted by Fitbit, Inc. (San Francisco, US). The FDA issued a Cleared decision on April 8, 2022 after a review of 252 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.

View all Fitbit, Inc. devices

Submission Details

510(k) Number K212372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2021
Decision Date April 08, 2022
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
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
NCT04380415 Completed Interventional Industry-sponsored

Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch

Fitbit Atrial Fibrillation From PPG Data Validation Study

450000
Patients (actual)
2
Sites
Diagnostic
Purpose
Single blind
Masking
Condition studied Atrial Fibrillation
Study design Sequential
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Steven Lubitz, MD, MPH
Sponsor Fitbit LLC (industry)
Started 2020-05-06 → Primary completion 2021-03-08
Primary outcome
Simultaneous measurement of AF ≥ 30 seconds with detection
Secondary outcome
Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov