510(k) K253412

Tablo Hemodialysis System (PN-0008000, PN-0006000U) by Outset Medical, Inc. — Product Code KDI

K253412 is an FDA 510(k) premarket notification submitted by Outset Medical, Inc. for the device "Tablo Hemodialysis System (PN-0008000, PN-0006000U)". The FDA issued a decision of Substantially Equivalent on January 26, 2026. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Outset Medical, Inc. has at least 9 other 510(k) clearances on record.