Cleared Special

K130957 - WVSM (WIRLESS VITAL SIGNS MONITOR)

K130957 is an FDA 510(k) clearance for WVSM (WIRLESS VITAL SIGNS MONITOR), manufactured by Athena Gtx. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 25-day FDA review.

K130957 · Athena Gtx · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
25d
Days
Class 2
Risk

K130957 is an FDA 510(k) clearance for the WVSM (WIRLESS VITAL SIGNS MONITOR). Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Athena Gtx (Des Moines, US). The FDA issued a Cleared decision on April 30, 2013 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Athena Gtx devices

FDA 510(k) Submission Details - K130957

510(k) Number K130957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2013
Decision Date April 30, 2013
Days to Decision 25 days
Submission Type Special
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
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

MWI Device Classification - Class 2, Special Controls

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 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K130957.
TEMPUS PRO PATIENT MONITOR
K130773 · Remote Diagnostic Technologies , Ltd. · Jun 2013
740 SELECT
K130411 · Cas Medical Systems, Inc. · May 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K130796 · Covidien · May 2013
PATIENT MONITOR
K130056 · Ld Technology, LLC · Apr 2013
NUVON VITALS CHARTING SYSTEM
K130234 · Nuvon, Inc. · Mar 2013
VITAL SYNC SYSTEM
K123002 · Covidien, Formerly Nellcor Puritan Bennett, Inc. · Feb 2013