Cleared Special

K080807 - BLOOD TUBING SETS (STERILE FLUID PATH)

K080807 is an FDA 510(k) clearance for BLOOD TUBING SETS (STERILE FLUID PATH), manufactured by Nxstage Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Special 510(k) pathway after a 119-day FDA review.

K080807 · Nxstage Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
119d
Days
Class 2
Risk

K080807 is an FDA 510(k) clearance for the BLOOD TUBING SETS (STERILE FLUID PATH). Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Nxstage Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on July 18, 2008 after a review of 119 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K080807

510(k) Number K080807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2008
Decision Date July 18, 2008
Days to Decision 119 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
12d faster than avg
Panel avg: 131d · This submission: 119d
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 65
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K080807.
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
K120823 · Fresenius Medical Care North America, Design Cente · Jun 2012
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
K100364 · Gambro Renal Products, Inc. · Nov 2010
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc. · Feb 2009
GAMBRO CARTRIDGE BLOOD SETS
K070414 · Gambro Renal Products · Oct 2007
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
K072024 · Nipro Medical Corp. · Oct 2007
EDWARDS AQUALINE STERILE TUBING SET
K063293 · Edwards Lifesciences Services GmbH · Mar 2007