FDA applicant
Lg Electronics.Inc
FDA records 34 decisions for Lg Electronics.Inc (Gumi-Si, KR) from 2014 to 2026: 34 510(k) clearances. Most are in product codes PGY (Display, Diagnostic Radiology) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 60 for FDA’s reviews in the same codes and years. Its devices cite 42 predicates, 27 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Lg Electronics”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lg Electronics.Inc’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Lg Electronics.Inc’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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