Cleared Traditional

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 (K030442) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K030442 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Jul 2003
Decision
160d
Days
Class 2
Risk

K030442 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 July 21, 2003 after a review of 160 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K030442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date July 21, 2003
Days to Decision 160 days
Submission Type Traditional
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
30d slower than avg
Panel avg: 130d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K030442.
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K101261 · C.R. Bard, Inc. · Jul 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K063446 · C.R. Bard, Inc. · Dec 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K022561 · C.R. Bard, Inc. · Aug 2002
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015 · C.R. Bard, Inc. · Jun 2001