Cleared Special

K063446 - CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000

K063446 is an FDA 510(k) clearance for CATHETER REPAIR KIT WITH REPLACEMENT CO..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code NFK cleared through the Special 510(k) pathway after a 30-day FDA review.

K063446 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
30d
Days
Class 2
Risk

K063446 is an FDA 510(k) clearance for the CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000. Classified as Kit, Repair, Catheter, Hemodialysis (product code NFK), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 15, 2006 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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.

FDA 510(k) Submission Details - K063446

510(k) Number K063446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2006
Decision Date December 15, 2006
Days to Decision 30 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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

NFK Device Classification - Class 2, Special Controls

Product Code NFK Kit, Repair, Catheter, Hemodialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition Hemodialysis Tray
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 - NFK Kit, Repair, Catheter, Hemodialysis

All 10
Devices cleared under the same product code (NFK) and FDA review panel - the closest regulatory comparables to K063446.
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K101261 · C.R. Bard, Inc. · Jul 2010
ACUTE AND CHRONIC CATHETER REPAIR KIT
K092797 · Kendall · Nov 2009
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
K062435 · Spire Biomedical, Inc. · Dec 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K030442 · C.R. Bard, Inc. · Jul 2003
RETRO REPAIR KIT, MODEL PRRK5
K022644 · Spire Biomedical, Inc. · Nov 2002
MEDCOMP REPAIR KIT, MODEL ASPCRPK
K022570 · Medcomp · Oct 2002
K063446 · CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
Download PDF FDA Summary C.R. Bard, Inc.