Cleared Special

K072024 - NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693

K072024 is an FDA 510(k) clearance for NIPRO BLOOD TUBING SET WITH TRANSDUCER ..., manufactured by Nipro Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Special 510(k) pathway after a 72-day FDA review.

K072024 · Nipro Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
72d
Days
Class 2
Risk

K072024 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-.... Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Miami, US). The FDA issued a Cleared decision on October 4, 2007 after a review of 72 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nipro Medical Corp. devices

FDA 510(k) Submission Details - K072024

510(k) Number K072024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2007
Decision Date October 04, 2007
Days to Decision 72 days
Submission Type Special
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
59d faster than avg
Panel avg: 131d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 61
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K072024.
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc. · Feb 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
K080807 · Nxstage Medical, Inc. · Jul 2008
GAMBRO CARTRIDGE BLOOD SETS
K070414 · Gambro Renal Products · Oct 2007
EDWARDS AQUALINE STERILE TUBING SET
K063293 · Edwards Lifesciences Services GmbH · Mar 2007
GAMBRO QUICKSET BLOODLINES
K063290 · Gambro Renal Products · Jan 2007
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
K012242 · Fresenius Medical Care North America · Aug 2001