FDA applicant
UC-CARE, Ltd.
FDA records 6 decisions for UC-CARE, Ltd. (Yokneam, IL) from 2009 to 2026: 6 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and GEH (Unit, Cryosurgical, Accessories). Since 2016 its 510(k)s took a median of 173 days from receipt to decision, against 133 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 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 UC-CARE, 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 2009.
Planning a device like UC-CARE, 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