# K243305: Masimo W1

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Apr 3, 2025 after 164 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963725 (1997). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240229: Masimo W1, Masimo Corporation (2024) Summary page 5.
- K201456: Scan Monitor, Withings SA (2021) Summary page 5.
- K201168: ECG Monitor App, Samsung Electronics Co., Ltd. (2020) Summary page 5.

## Indications for use
Masimo W1™ and the integrated Masimo W1 Module are intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Masimo W1 also displays ECG rhythms, and the Masimo W1 Module detects the presence of atrial fibrillation. The Masimo W1 and the integrated Masimo W1 Module are intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. Masimo W1 Module ECG software is an over-the-counter (OTC) software that operates on the Masimo W1 Module that can be used with compatible watches (e.g., Masimo W1). The software is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG) for informational use only in adults 22 years and older. It supports the classification of either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The software is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The Masimo W1™ and the integrated Masimo W1 Module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 and the integrated Masimo W1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

Source page: https://510kreport.com/device/K243305
Methodology: https://510kreport.com/methodology