Athena Gtx: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Athena Gtx” (first 2010, latest 2024), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 131 days. Since 2017 the median was 188 days, against 197 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 99 |
| 2013 | 1 | 25 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 122 |
| 2017 | 0 | — |
| 2018 | 1 | 163 |
| 2019 | 0 | — |
| 2020 | 1 | 188 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 271 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Athena Gtx took a median 188 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 197 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 5 | 5 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 | 1 |
Review panels
Most recent Athena Gtx 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233354 | WVSM Pro (Series) (500-0030-XX) | MWI | 2024-06-26 | 271 |
| K191989 | WVSM (Wireless Vital Signs Monitor) RWC + miniCap | MWI | 2020-01-29 | 188 |
| K173203 | Athena GTX Device Management Suite (ADMS) Software | MSX | 2018-03-14 | 163 |
| K160582 | WiCap | DQA | 2016-09-02 | 185 |
| K153459 | TACVAC | BTA | 2016-01-28 | 58 |
| K130957 | WVSM (WIRLESS VITAL SIGNS MONITOR) | MWI | 2013-04-30 | 25 |
| K113165 | MINI-MEDIC | MWI | 2012-02-02 | 99 |
| K101674 | WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 | MWI | 2010-07-21 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Athena Gtx.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Athena Technology, Inc. (3 510(k)s)
- Athena Feminine Technologies, Inc. (2 510(k)s)
- Athena Medical Corp. (2 510(k)s)
- Athena Mfg., Inc. (1 510(k)s)
- Athena Surgical, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Athena Gtx?
FDA lists 8 510(k) clearances under the applicant name “Athena Gtx” (first 2010, latest 2024), across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Athena Gtx?
The median time from FDA receipt to decision across 510(k)s cleared under the name Athena Gtx is 131 days. Since 2017: 188 days, versus 197 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Athena Gtx?
The most frequent FDA product codes under this applicant name are MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 5); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1); DQA (Oximeter, 1).
Next steps
- See all 8 Athena Gtx clearances with predicates and recalls
- Run predicate analysis for product code MWI, Athena Gtx's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.