FDA applicant
Monitex Industrial Co., Ltd.
FDA records 9 decisions for Monitex Industrial Co., Ltd. (New Taipei City, TW) from 2005 to 2017: 9 510(k) clearances. All are in product code EBZ (Activator, Ultraviolet, For Polymerization). Since 2016 its 510(k)s took a median of 509 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Monitex Industrial Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2017
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Monitex Industrial 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