Cleared Traditional

K243305 - Masimo W1

K243305 is an FDA 510(k) clearance for Masimo W1, manufactured by Masimo Corporation. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K243305 · Masimo Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
164d
Days
Class 2
Risk

K243305 is an FDA 510(k) clearance for the Masimo W1. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on April 3, 2025 after a review of 164 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Masimo Corporation devices

FDA 510(k) Submission Details - K243305

510(k) Number K243305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2024
Decision Date April 03, 2025
Days to Decision 164 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 403
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K243305.
Withings BeamO (SCT02)
K252474 · Withings · Nov 2025
Cardiologs Holter Platform
K250569 · Philips France Commercial · Aug 2025
ZBPro Diagnostic
K243252 · Zbeats, Inc. · Jul 2025
CloudHRV™ System (100-01-001)
K241217 · Inmedix, Inc. · Jan 2025
Cardiac Workstation (5000)
K241556 · Philips Medizin Systeme B?blingen GmbH · Dec 2024
Masimo W1
K240229 · Masimo Corporation · Aug 2024