FDA applicant
Chien TI Enterprise Co., Ltd.
FDA records 3 decisions for Chien TI Enterprise Co., Ltd. (New Taipei City, Hsin Chuang District, TW) from 2017 to 2019: 3 510(k) clearances. All are in product code INI (Vehicle, Motorized 3-Wheeled). Since 2016 its 510(k)s took a median of 191 days from receipt to decision, against 266 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Chien TI Enterprise Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Chien TI Enterprise 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) ReportOther applicant names beginning “Chien”
FDA records each applicant name separately; these may or may not be the same firm.