FDA applicant
Xsirius Medical, Inc.
FDA records 1 decision for Xsirius Medical, Inc. (Rolling Hills Estates, CA) in 1986: 1 510(k) clearance. All are in product code KDT (Container, Specimen Mailer And Storage, Sterile). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Xsirius Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Xsirius Medical, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Xsirius Medical, Inc.’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 “Xsirius”
FDA records each applicant name separately; these may or may not be the same firm.