FDA applicant
General Electric Co.
FDA records 256 decisions for General Electric Co. (Milwaukee, WI) from 1976 to 2011: 256 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 79 predicates, 31 of them its own earlier devices. 61 recalls are linked to its devices, 1 Class I.
FDA’s records also spell it “General Electric Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided General Electric Co.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2011
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like General Electric Co.’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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