Cleared Traditional

WUNDCATH CONDUCTION CATHETER (K003966) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003966 · Micor, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
207d
Days
Class 2
Risk

K003966 is an FDA 510(k) clearance for the WUNDCATH CONDUCTION CATHETER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Micor, Inc. (Allison Park, US). The FDA issued a Cleared decision on July 17, 2001 after a review of 207 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Micor, Inc. devices

Submission Details

510(k) Number K003966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2000
Decision Date July 17, 2001
Days to Decision 207 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 129d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 236
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K003966.
MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
K020947 · Smith & Nephew, Inc. · Apr 2002
STRYKER PAINPUMP
K014091 · Stryker Corp. · Dec 2001
HORIZON OUTLOOK WITH DOSECOM
K011975 · B.Braun Medical, Inc. · Sep 2001
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
K011442 · Abbott Laboratories · Jun 2001
COLLEAGUE VOLUMETRIC INFUSION PUMP
K010566 · Baxter Healthcare Corp · May 2001
ABBOTT ACCLAIM ENCORE, MODEL 12237
K011096 · Abbott Laboratories · May 2001