Cleared Traditional

K160881 - Tablo Console

K160881 is an FDA 510(k) clearance for Tablo Console, manufactured by Outset Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K160881 · Outset Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
230d
Days
Class 2
Risk

K160881 is an FDA 510(k) clearance for the Tablo Console. 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 November 15, 2016 after a review of 230 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Outset Medical, Inc. devices

FDA 510(k) Submission Details - K160881

510(k) Number K160881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2016
Decision Date November 15, 2016
Days to Decision 230 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 130d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

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

All 227
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K160881.
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Optiflux dialyzer
K152367 · Fresenius Medical Care North America · Oct 2015