FDA.reportPublic FDA data

Irregular Rhythm Notification feature 2.0

Primary DI
00194252456774
Brand
Irregular Rhythm Notification feature 2.0
Company
APPLE INC.
Model
Feature Version 2.x
Device description
Irregular Rhythm Notification feature Watch App (Version 2.0)
Published
2022-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDBPhotoplethysmograph Analysis Software For Over-The-Counter UseCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212516000IRNF AppApple, Inc.2021-10-22QDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194252456774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194252456774001942524567741942524567740194252456774

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
060704780
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195950591545Medical Imaging Calibration Feature (MICF)Feature version 1.X2026-04-23
00195950591552Medical Imaging Calibration Feature (MICF)Feature version 1.X2026-04-23
00190199649286ECG 2.0 AppFeature Version 2.x2020-12-15
00190199649293ECG 2.0 AppFeature Version 2.x2020-12-15
00190198909534ECG AppFeature Version 1.x2019-01-14
00190198909541ECG AppFeature Version 1.x2019-01-14
00195949001789Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949001796Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949948411Digital Prism Correction Feature (DPCF)Feature version 1.X2025-09-11
00195950732382Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732399Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732405Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732412Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195949149931Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00194253312512Cycle Tracking 4.0Feature Version 4.x2024-11-01
00194253312529Cycle Tracking 4.0Feature Version 4.x2024-11-01
00195949149924Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00195949149948Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195949149955Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195950095067Hearing Aid Feature (HAF)Feature version 1.X2024-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810028737778Google Irregular Rhythm NotificationsFitbit LLCQDB2026-05-20
08806094948233Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDB2025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)Samsung Electronics Co., Ltd.QDB2025-06-10
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDB2023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationSamsung Electronics Co., Ltd.QDB2023-10-23
00194252456798Atrial Fibrillation History FeatureAPPLE INC.QDB2022-09-12
00194252456804Atrial Fibrillation History FeatureAPPLE INC.QDB2022-09-12
00810038852720 Fitbit Irregular Rhythm NotificationsFitbit LLCQDB2022-04-25
00194252456781Irregular Rhythm Notification feature 2.0APPLE INC.QDB2022-03-14
00190198909510Irregular Rhythm NotificationsAPPLE INC.QDB2019-01-14
00190198909527Irregular Rhythm Notifications APPLE INC.QDB2019-01-14