Cleared Traditional

Tablo Hemodialysis System, Tablo Cartridge

K190793 · Outset Medical, Inc. · Gastroenterology & Urology

Dec 2019

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K190793 is an FDA 510(k) clearance for the Tablo Hemodialysis System, Tablo Cartridge, 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 December 12, 2019, 259 days after receiving the submission on March 28, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.

Submission Details

510(k) Number	K190793 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2019
Decision Date	December 12, 2019
Days to Decision	259 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