FDA applicant
Oxytek Medical Technology Co., Ltd.
FDA records 2 decisions for Oxytek Medical Technology Co., Ltd. (Chencun Town, Shunde District, Foshan, CN) in 2026: 2 510(k) clearances. All are in product code CAW (Generator, Oxygen, Portable). Its devices cite 2 predicates, 0 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 Oxytek Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Oxytek Medical 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