WVSM (Wireless Vital Signs Monitor) RWC + miniCap— 510(k) K191989

Name: FDA 510(k) clearance K191989
Creator: U.S. Food and Drug Administration
Published: 2020-01-29

Substantially Equivalent

Athena Gtx

FDA 510(k) clearance K191989 for WVSM (Wireless Vital Signs Monitor) RWC + miniCap, Substantially Equivalent on 2020-01-29. Applicant: Athena Gtx. Device class: 2.

Clearance details

Applicant: Athena Gtx
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2019-07-25
Decision date: 2020-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Johnson, IA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWI

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K260438 — Vital Signs Monitor (CLEO2)2026-08-14
K253417 — Masimo Root Monitoring System2026-08-12
K253196 — Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)2026-06-12
K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Athena Gtx

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K173203 — Athena GTX Device Management Suite (ADMS) Software2018-03-14
K160582 — WiCap2016-09-02
K153459 — TACVAC2016-01-28
K130957 — WVSM (WIRLESS VITAL SIGNS MONITOR)2013-04-30
K113165 — MINI-MEDIC2012-02-02

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.