FDA applicant
Assure Tech. (Hangzhou) Co, Ltd.
FDA records 7 decisions for Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN) from 2016 to 2024: 7 510(k) clearances. Most are in product codes NFT (Test, Amphetamine, Over The Counter) and LCX (Kit, Test, Pregnancy, Hcg, Over The Counter). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 1 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 Assure Tech. (Hangzhou) Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Assure Tech. (Hangzhou) 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 “Assure”
FDA records each applicant name separately; these may or may not be the same firm.