FDA applicant
APK Technology Co., Ltd.
FDA records 7 decisions for APK Technology Co., Ltd. (Shenzhen, CN) from 1991 to 2025: 7 510(k) clearances. Most are in product codes DQA (Oximeter) and LRP (Tray, Surgical). Since 2016 its 510(k)s took a median of 60 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Apk Technology”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided APK Technology 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 2007.
Planning a device like APK 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