FDA applicant
Mckesson Information Solutions, LLC
FDA records 1 decision for Mckesson Information Solutions, LLC (Philedelphia, PA) in 2011: 1 510(k) clearance. All are in product code HGM (System, Monitoring, Perinatal). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Mckesson Information Solutions, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Mckesson Information Solutions, LLC’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 “Mckesson”
FDA records each applicant name separately; these may or may not be the same firm.