About This 510(k) Submission
K253412 is an FDA 510(k) clearance for the Tablo Hemodialysis System (PN-0008000, PN-0006000U), a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Outset Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on January 26, 2026, 118 days after receiving the submission on September 30, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.