FDA applicant
Safecare Biotech (Hangzhou) Co., Ltd.
FDA records 9 decisions for Safecare Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN) from 2016 to 2025: 9 510(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 61 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 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 Safecare Biotech (Hangzhou) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Safecare Biotech (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) Report