Cleared Special

K112628 - NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET

K112628 is an FDA 510(k) clearance for NIPRO BLOOD TUBING SET WITH TRANSDUCER ..., manufactured by Nipro Medical Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Special 510(k) pathway after a 385-day FDA review.

K112628 · Nipro Medical Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
385d
Days
Class 2
Risk

K112628 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on September 28, 2012 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K112628

510(k) Number K112628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2011
Decision Date September 28, 2012
Days to Decision 385 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
254d slower than avg
Panel avg: 131d · This submission: 385d
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 76
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K112628.
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K090255 · Nxstage Medical, Inc. · Feb 2009
K112628 · NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
Download PDF FDA Summary Nipro Medical Corpora…