About This 510(k) Submission
K250508 is an FDA 510(k) clearance for the AK 98 Dialysis Machine (955607), a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Vantive US Healthcare, LLC (Deerfield Lake, US). The FDA issued a Cleared decision on August 1, 2025, 161 days after receiving the submission on February 21, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.