About This 510(k) Submission
K250404 is an FDA 510(k) clearance for the stay?safe? catheter extension set with Safe- Lock, 12 inch; stay?safe? catheter extension set with Luer-Lock, 6 inch; stay?safe? catheter extension set with Luer-Lock, 12 inch; stay?safe? catheter extension set with Luer-Lock, 18 inch; stay?safe? to Luer-Lock Adapter, 4 inch, a Set, Administration, For Peritoneal Dialysis, Disposable (Class II — Special Controls, product code KDJ), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on April 3, 2025, 50 days after receiving the submission on February 12, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.