FDA 510(k) · Masimo
K240229: Masimo W1 (Masimo Corporation)
Masimo Corporation received FDA 510(k) K240229 for Masimo W1, with a decision date of Aug 8, 2024 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K240229 |
|---|---|
| Pathway | 510(k) |
| Applicant | Masimo Corporation |
| Device name | Masimo W1 |
| Product code | DPS: Electrocardiograph |
| Regulation (21 CFR) | 870.2340 |
| Device class | Class 2 |
| Date received | Jan 29, 2024 |
| Decision date | Aug 8, 2024 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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 the spot-checking of other continuous parameters (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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K232512 Masimo W1 (Masimo)
Later records that cite K240229
- K243305 Masimo W1 (Masimo, Apr 3, 2025, DPS)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DPS is "Electrocardiograph", class 2, 21 CFR 870.2340.
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.