Cleared Traditional

Tablo Hemodialysis System

K211370 · Outset Medical, Inc. · Gastroenterology & Urology

Jul 2022

Decision

451d

Days

Class 2

Risk

About This 510(k) Submission

K211370 is an FDA 510(k) clearance for the Tablo Hemodialysis System, 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 July 29, 2022, 451 days after receiving the submission on May 4, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K211370 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2021
Decision Date	July 29, 2022
Days to Decision	451 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5860