Irregular Rhythm Notification Feature (IRNF) Software
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Apple Inc.
Identity
- Trade Name
- Irregular Rhythm Notification feature 2.0 FDA UDI
- Generic Name
- Self-care monitoring/reporting software FDA UDI
- Device Name
- Irregular Rhythm Notification Feature EUDAMEDIrregular Rhythm Notification feature Watch App (Version 2.0) FDA UDI
- Model / Reference
- 2.X EUDAMEDIrregular Rhythm Notification Feature 2.X EUDAMEDFeature Version 2.x FDA UDI
- Description
- Irregular Rhythm Notification feature Watch App (Version 2.0) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00194252456774 EUDAMEDFDA UDI
- Basic UDI-DI
- 0194252IRNFeature22Q EUDAMED
- Direct Marketing DI
- 00194252456774 EUDAMED
- FDA Product Code
- QDB FDA 510(k)FDA UDI
- EMDN Code
- Z12039092 VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Self-care monitoring/reporting software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2790 FDA 510(k)
- Regulation Number
- 870.2790 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Irregular Rhythm Notification Feature (IRNF) is a photoplethysmograph analysis software designed for over-the-counter use. It detects and alerts users to potential irregular heart rhythms through continuous monitoring via compatible wearable devices, functioning as a diagnostic aid for cardiovascular assessment.
Supplied as a digital application, the IRNF operates on compatible Apple devices and is intended for single-use per session without sterility requirements. It adheres to FDA 510(k) clearance (K231173) and EU MDR compliance, classified under device class II for cardiovascular monitoring. No physical storage or MRI safety considerations apply, as it is purely software-based.
Frequently asked questions
How does the Irregular Rhythm Notification Feature (IRNF) work and what wearable devices is it compatible with?
The IRNF is a software-based diagnostic aid that uses photoplethysmography (PPG) analysis to continuously monitor heart rhythms through compatible Apple wearable devices. It detects potential irregularities and alerts users via their Apple device, functioning as an over-the-counter tool for cardiovascular assessment. Compatibility is limited to Apple-branded wearables designed to support PPG monitoring.
Is the IRNF designed for repeated use or single sessions, and does it require sterilization?
The IRNF is intended for single-use per monitoring session, as it is a software application rather than a physical device. Since it operates digitally and does not involve direct patient contact or physical components, there are no sterility requirements. Users can restart the feature for new monitoring sessions as needed.
What regulatory approvals does the IRNF hold, and how does it classify under medical device regulations?
The IRNF holds FDA 510(k) clearance (K231173) and complies with EU MDR standards. It is classified as a Class II cardiovascular monitoring device under both regulatory frameworks, indicating it is intended for detecting potential irregular heart rhythms as a diagnostic aid.
Does the IRNF require any special storage conditions or considerations, such as MRI safety?
Since the IRNF is purely software-based and operates on Apple devices, no physical storage or environmental conditions (like temperature or humidity) are required. Additionally, there are no MRI safety concerns, as the feature does not involve hardware that could be affected by magnetic fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231173 | Class II | Active |
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Manufacturer
- Manufacturer
- Apple Inc.
- FDA Applicant
- Apple, Inc.
Sources (3)
- FDA 510(k) K231173 24 fields · synced Sep 18, 2026
- FDA UDI 8d8d9c39-a9d2-4ad2-b16b-738b1c53d626 34 fields · synced May 30, 2026
- EUDAMED a4fad75f-4b5d-492e-a0c9-d084847a2166 61 fields · synced Jul 18, 2026