Data / Medical devices / United States / Athena GTX

Athena GTX: FDA-registered device maker in Johnston, IA, United States, 4 510(k) clearances

Name: Athena GTX FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Athena GTX is registered with the FDA (registration 3007413079) in Johnston, IA, United States. It lists 12 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 26, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007413079
Address: 5900 NW 86th St Ste 300, Johnston, IA, United States, 50131
Owner or operator: Athena GTX (10034326)
Roles: Complaint file establishment, Manufacturer, Remanufacturer
First device listed: November 23, 2010
Registered through: 2026
Brand names listed: ADMS, WVSM, WVSM Pro (Series) (500-0030-XX), WVSM RWC + miniCap

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Detector And Alarm, Arrhythmia	DSI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electrocardiograph	DPS	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Monitor, St Segment With Alarm	MLD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
System, Network And Communication, Physiological Monitors	MSX	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Complaint file establishment, Manufacturer, Remanufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 26, 2024	K233354	WVSM Pro (Series) (500-0030-XX)	MWI	Substantially Equivalent	Athena Gtx, Inc.	accessdata.fda.gov
January 29, 2020	K191989	WVSM (Wireless Vital Signs Monitor) RWC + miniCap	MWI	Substantially Equivalent	Athena Gtx	accessdata.fda.gov
March 14, 2018	K173203	Athena GTX Device Management Suite (ADMS) Software	MSX	Substantially Equivalent	Athena Gtx	accessdata.fda.gov
July 21, 2010	K101674	WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0	MWI	Substantially Equivalent	Athena Gtx	accessdata.fda.gov

Compare with other makers

Updated June 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.