FDA applicant
Sturdy Industrial Co., Ltd.
FDA records 3 decisions for Sturdy Industrial Co., Ltd. (New Taipei City, TW) from 2004 to 2023: 3 510(k) clearances. Most are in product codes FLE (Sterilizer, Steam) and BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 2 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 Sturdy Industrial Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Sturdy Industrial 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