FDA applicant
Cerner Corp.
FDA records 8 decisions for Cerner Corp. (Kansas City, MO) from 1996 to 2015: 8 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and HGM (System, Monitoring, Perinatal). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Cerner Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cerner Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cerner Corp.’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) Report