FDA applicant
Joytech Healthcare Co., Ltd.
FDA records 24 decisions for Joytech Healthcare Co., Ltd. (Hangzhou, CN) from 2017 to 2026: 24 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Since 2016 its 510(k)s took a median of 175 days from receipt to decision, against 171 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 12 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “JOYTECH Healthcare Co., Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Joytech Healthcare Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Joytech Healthcare 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