FDA applicant
Ixensor Co, Ltd.
FDA records 3 decisions for Ixensor Co, Ltd. (Taipei City, TW) from 2017 to 2019: 3 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 269 for FDA’s reviews in the same codes and years. 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 “Ixensor Company , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ixensor Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Ixensor Co, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report