Athena GTX
Johnston, IA, US
ATHENA GTX appears in FDA device records in Johnston, IA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Athena GTX between 2010 and 2024. The busiest year on record is 2016, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 2 |
| 2018 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233354 | WVSM Pro (Series) (500-0030-XX) | MWI | Substantially Equivalent | |
| K191989 | WVSM (Wireless Vital Signs Monitor) RWC + miniCap | MWI | Substantially Equivalent | |
| K173203 | Athena GTX Device Management Suite (ADMS) Software | MSX | Substantially Equivalent | |
| K160582 | WiCap | DQA | Substantially Equivalent | |
| K153459 | TACVAC | BTA | Substantially Equivalent | |
| K130957 | WVSM (WIRLESS VITAL SIGNS MONITOR) | MWI | Substantially Equivalent | |
| K113165 | MINI-MEDIC | MWI | Substantially Equivalent | |
| K101674 | WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 | MWI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007413079 | 3007413079 | ATHENA GTX | 5900 NW 86th St Ste 300, Johnston, IA 50131 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- MLDMonitor, St Segment With Alarm
- DQAOximeter
- BTAPump, Portable, Aspiration (Manual Or Powered)
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- MSXSystem, Network And Communication, Physiological Monitors
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain