Cleared Traditional

K140866 - TABLO CONSOLE

K140866 is an FDA 510(k) clearance for TABLO CONSOLE, manufactured by Home Dialysis Plus. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K140866 · Home Dialysis Plus · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Sep 2014
Decision
160d
Days
Class 2
Risk

K140866 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 Home Dialysis Plus (Sunnyvale, US). The FDA issued a Cleared decision on September 10, 2014 after a review of 160 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 Home Dialysis Plus devices

FDA 510(k) Submission Details - K140866

510(k) Number K140866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2014
Decision Date September 10, 2014
Days to Decision 160 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
29d slower than avg
Panel avg: 131d · This submission: 160d
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 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K140866.
Optiflux dialyzer
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ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
K133299 · Fresenius Medical Care, North America - Renal Ther · Jul 2014
NXSTAGE SYSTEM ONE
K140526 · Nxstage Medical, Inc. · May 2014
ELISIO-H HEMODIALYZER
K140191 · Nipro Medical Corporation · Apr 2014