FDA applicant
Degania Silicone, Ltd.
FDA records 19 decisions for Degania Silicone, Ltd. (Emek Hayarden, IL) from 1988 to 2026: 19 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and EZL (Catheter, Retention Type, Balloon). Since 2016 its 510(k)s took a median of 205 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 3 of them its own earlier devices. 69 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Degania Silicone, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
11in 2020
Class I Class II/III not classified
Planning a device like Degania Silicone, 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