FDA applicant
Tianjin Huahong Technology Co., Ltd.
FDA records 16 decisions for Tianjin Huahong Technology Co., Ltd. (Tianjin, CN) from 2021 to 2026: 16 510(k) clearances. Most are in product codes FMK (Single Use Only Blood Lancet With An Integral…) and QRL (Multiple Use Blood Lancet For Single Patient…). Since 2016 its 510(k)s took a median of 67 days from receipt to decision, against 68 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 10 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 Tianjin Huahong Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Tianjin Huahong Technology 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