FDA applicant
Uzinmedicare Co.
FDA records 12 decisions for Uzinmedicare Co. (Gyeonggi-Do, KR) from 2010 to 2026: 12 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). Since 2016 its 510(k)s took a median of 256 days from receipt to decision, against 142 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 8 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Uzinmedicare Co., Ltd.”, “Uzinmedicare Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Uzinmedicare Co.’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 2010.
Planning a device like Uzinmedicare Co.’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