Atlas FDA

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

Argosy Intl. (Usa), Inc. · Predicate Candidate Screening

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

9 daysmedian FDA review time
20 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823075REXTONArgosy Intl. (Usa), Inc.1982-11-08200
K791548REXTON HS(HEARING SYSTEM)Argosy Intl. (Usa), Inc.1979-09-28460
K781094HEARING AID, EYEGLASSArgosy Intl. (Usa), Inc.1978-07-17170
K781096HEARING AID, EYEGLASS, B-12Argosy Intl. (Usa), Inc.1978-07-17170
K781095HEARING AID, BEHIND THE EARArgosy Intl. (Usa), Inc.1978-07-17170
K780917PRIMO CE (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490
K780916780 UE (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490
K780915780 SE (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490
K780920MM-CE 11 (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490
K780918PRIMO CEDM (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490
K780914PM 25 PP (BODY AID)Argosy Intl. (Usa), Inc.1978-06-1490
K780922UM VII (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490
K780921MM-CE DM (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490
K780919M25 PP (BEHIND THE EAR)Argosy Intl. (Usa), Inc.1978-06-1490

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