Cleared 510(k) Submissions with Supporting Documents - 2026 | FDA

This list includes cleared 510(k) submissions for 2026 for which we have supporting documents available and reflects the information as of the clearance date. It is not updated with regard to applicant or application status change.The clearances are listed by clearance date in reverse chronological order.510(k) NumberApplicantDevice NameDecision DateBK251245Grifols Diagnostic Solutions Inc.San Diego, CA 92127Procleix® WNV/ Babesia Quality Control01/02/2026BK251207Techno-Path Manufacturing Ltd.IrelandMultichem ID-HIV p2401/02/2026