FDA applicant
Ge Medical Systems Information Technologies
FDA records 172 decisions for Ge Medical Systems Information Technologies (Wallingford, CT) from 1978 to 2026: 171 510(k) clearances and 1 original PMA approval. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and HGM (System, Monitoring, Perinatal). Since 2016 its 510(k)s took a median of 149 days from receipt to decision, against 190 for FDA’s reviews in the same codes and years. Its devices cite 162 predicates, 71 of them its own earlier devices. 124 recalls are linked to its devices.
FDA’s records also spell it “Ge Medical Systems Information Technologies, Inc.”, “Ge Medical Systems Information Technologies GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ge Medical Systems Information Technologies’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
14in 2026
Class I Class II/III not classified
Planning a device like Ge Medical Systems Information…’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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