FDA applicant
Shandong Kangli Medical Equipment Technology Co., Ltd.
FDA records 1 decision for Shandong Kangli Medical Equipment Technology Co., Ltd. (Zaozhuang, CN) in 2020: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). 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 Shandong Kangli Medical Equipment Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2020high 1 (2020) · low 0 (2021)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Shandong Kangli Medical Equipment…’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