FDA applicant
Athena Gtx
FDA records 8 decisions for Athena Gtx (Johnson, IA) from 2010 to 2024: 8 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and DQA (Oximeter). Since 2016 its 510(k)s took a median of 185 days from receipt to decision, against 149 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 4 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Athena Gtx, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Athena Gtx’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Athena Gtx’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Athena”
FDA records each applicant name separately; these may or may not be the same firm.