510(k) Report

FDA applicant

Cerner Corp.

Kansas City, MO8 decisions1996–20150 recalls

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, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Cerner Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2007: 12009: 32012: 12015: 1
2007high 3 (2009) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cerner Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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