Cleared Traditional

Tablo Hemodialysis System (K200741) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K200741 · Outset Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
8d
Days
Class 2
Risk

K200741 is an FDA 510(k) clearance for the Tablo Hemodialysis System. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Outset Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on March 31, 2020 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Outset Medical, Inc. devices

Submission Details

510(k) Number K200741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2020
Decision Date March 31, 2020
Days to Decision 8 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 130d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02460263 Completed Interventional Industry-sponsored

The EvAluation of TaBlo In-CLinic and In-HOme

A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the Tablo Hemodialysis System In-Center and In-Home by Subjects With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens

30
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied End Stage Renal Disease
Study design Sequential
Eligibility All sexes · 18 Years+
Sponsor Outset Medical (industry)
Started 2015-12-01 → Primary completion 2019-05-01
Primary outcome
Weekly Standardized Dialysis Adequacy
Secondary outcome
Ultrafiltration Rate Success
View full study on ClinicalTrials.gov

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 77
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K200741.
Optiflux F180NR Dialyzer
K192707 · Fresenius Medical Care Renal Therapies Group, LLC · Sep 2020
DIMI RRT System
K193005 · Dialco Medical, Inc. · Aug 2020
Optiflux Enexa F500 Dialyzer
K192928 · Fresenius Medical Care Reanal Therapies Group, LLC · Jul 2020
PrisMax System Version 3
K193482 · Baxter Healthcare Corporation · Mar 2020
Aquadex FlexFlow System 2.0
K192756 · Chf Solutions, Inc. · Feb 2020
Tablo Hemodialysis System, Tablo Cartridge
K190793 · Outset Medical, Inc. · Dec 2019