Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Athena Gtx — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

99 daysmedian FDA review time
188 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K191989WVSM (Wireless Vital Signs Monitor) RWC + miniCapAthena Gtx2020-01-291880
K173203Athena GTX Device Management Suite (ADMS) SoftwareAthena Gtx2018-03-141630
K160582WiCapAthena Gtx2016-09-021850
K153459TACVACAthena Gtx2016-01-28580
K130957WVSM (WIRLESS VITAL SIGNS MONITOR)Athena Gtx2013-04-30250
K113165MINI-MEDICAthena Gtx2012-02-02990
K101674WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0Athena Gtx2010-07-21360

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda