FDA applicant
Assure Tech., LLC
FDA records 10 decisions for Assure Tech., LLC (Wilmington, DE) from 2015 to 2026: 10 510(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 35 days from receipt to decision, against 40 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Assure Tech. Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Assure Tech., LLC’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Assure Tech., LLC’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.