FDA applicant
Lucenxia Prescience AG
FDA records 9 decisions for Lucenxia Prescience AG (Baar, CH) from 2013 to 2018: 9 510(k) clearances. All are in product code KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 141 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Lucenxia Prescience AG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like Lucenxia Prescience AG’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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