FDA applicant
U&U Medical Technology Co, Ltd.
FDA records 10 decisions for U&U Medical Technology Co, Ltd. (Changzhou, CN) from 2013 to 2019: 10 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRG (Wrap, Sterilization). Since 2016 its 510(k)s took a median of 244 days from receipt to decision, against 165 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided U&U Medical Technology Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like U&U 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