Cleared Traditional

K191989 - WVSM (Wireless Vital Signs Monitor) RWC...

K191989 is the FDA 510(k) clearance for WVSM (Wireless Vital Signs Monitor) RWC... by Athena Gtx. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K191989 · Athena Gtx · Cardiovascular device
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Jan 2020
Decision
188d
Days
Class 2
Risk

K191989 is an FDA 510(k) clearance for the WVSM (Wireless Vital Signs Monitor) RWC + miniCap. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Athena Gtx (Johnson, US). The FDA issued a Cleared decision on January 29, 2020 after a review of 188 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 devices

Submission Details

510(k) Number K191989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2019
Decision Date January 29, 2020
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 123
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