FDA applicant
Shenzhen TPH Technology Co., Ltd.
FDA records 24 decisions for Shenzhen TPH Technology Co., Ltd. (Shenzhen, CN) from 2022 to 2026: 24 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 138 days from receipt to decision, against 142 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 20 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 Shenzhen TPH Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
11in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Shenzhen TPH 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