FDA applicant
Kingtech Enterprise, Ltd.
FDA records 3 decisions for Kingtech Enterprise, Ltd. (Kwai Chung, New Territories, HK) from 2011 to 2013: 3 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). 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 Kingtech Enterprise, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2013
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Kingtech Enterprise, 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