# K232512: Masimo W1

- Pathway: 510(k) (Traditional)
- Applicant: Masimo Corporation
- Decided: Nov 17, 2023 after 91 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: 6 generations back to K963725 (1997). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201456: Scan Monitor, Withings SA (2021) Summary page 4.

## Most influential descendants
- K240229: Masimo W1 (2024), 1 descendant of its own
- K243305: Masimo W1 (2025), 0 descendants of its own

## Indications for use
Masimo W1™ and the integrated Masimo W1 module are intended for the spot-check determination of Heart Rate using a single-channel electrocardiogram (ECG). The Masimo W1 and the integrated Masimo W1 module records, stores, transfers, and displays the single-channel ECG for the manual interpretation of heart rate. It is worn on the wrist and also provides other continuous parameters technologies (e.g., pulse oximetry). 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/K232512
Methodology: https://510kreport.com/methodology