Cleared Traditional

K140841 - TABLO CARTRIDGE

K140841 is an FDA 510(k) clearance for TABLO CARTRIDGE, manufactured by Home Dialysis Plus. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K140841 · Home Dialysis Plus · Gastroenterology & Urology device
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Sep 2014
Decision
162d
Days
Class 2
Risk

K140841 is an FDA 510(k) clearance for the TABLO CARTRIDGE. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Home Dialysis Plus (Sunnyvale, US). The FDA issued a Cleared decision on September 11, 2014 after a review of 162 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 - K140841

510(k) Number K140841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2014
Decision Date September 11, 2014
Days to Decision 162 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
31d slower than avg
Panel avg: 131d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 59
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K140841.
Dimesol Tubing Sets for Hemodialysis
K171952 · Dimesol, Inc. · Mar 2018
DORA Tubing Sets for Hemodialysis
K161582 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Jun 2017
Oxyless Blood Tubing Set
K150304 · Oxyless, Ltd. · Feb 2016
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · Nipro Medical Corporation · Sep 2012
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
K120823 · Fresenius Medical Care North America, Design Cente · Jun 2012
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc. · Feb 2009