Cleared Traditional

K120823 - BVM HEMODIALYSIS BLOOD TUBING SET WITH ...

K120823 is the FDA 510(k) clearance for BVM HEMODIALYSIS BLOOD TUBING SET WITH ... by Fresenius Medical Care North America, Design Cente. It is a Class 2 Gastroenterology & Urology device (product code FJK) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K120823 · Fresenius Medical Care North America, Design Cente · Gastroenterology & Urology device
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Jun 2012
Decision
88d
Days
Class 2
Risk

K120823 is an FDA 510(k) clearance for the BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PR.... Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Fresenius Medical Care North America, Design Cente (Waltham, US). The FDA issued a Cleared decision on June 15, 2012 after a review of 88 days - a notably fast clearance 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: 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 Fresenius Medical Care North America, Design Cente devices

Submission Details

510(k) Number K120823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2012
Decision Date June 15, 2012
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 42
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K120823.
NovaLine Tubing Sets for Hemodialysis
K201866 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Mar 2021
Dimesol Tubing Sets for Hemodialysis
K171952 · Dimesol, Inc. · Mar 2018
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
K112628 · Nipro Medical Corporation · Sep 2012
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc. · Feb 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
K080807 · Nxstage Medical, Inc. · Jul 2008
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
K012242 · Fresenius Medical Care North America · Aug 2001