Cleared Traditional

WVSM Pro (Series) (500-0030-XX) (K233354) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233354 · Athena Gtx, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
271d
Days
Class 2
Risk

K233354 is an FDA 510(k) clearance for the WVSM Pro (Series) (500-0030-XX). Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Athena Gtx, Inc. (Johnson, US). The FDA issued a Cleared decision on June 26, 2024 after a review of 271 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Athena Gtx, Inc. devices

Submission Details

510(k) Number K233354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date June 26, 2024
Days to Decision 271 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 125d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 111
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K233354.
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
K243216 · Analog Devices · Dec 2024
AMC Health CareConsole
K233446 · Amc Health · Sep 2024
Happy Ring Health Monitoring System
K240236 · Happy Health, Inc. · Sep 2024
NeoBeat, NeoBeat Mini
K232111 · Laerdal Medical AS · Jun 2024
Portrait VSM
K233810 · Ge Medical Systems Information Technologies, Inc. · Apr 2024
Talis EMR with Talis +ACG (Talis EMR with +ACG)
K233133 · Talis Clinical, LLC · Apr 2024