Cleared Traditional

VACUCATH I.V. CATHETER INTRODUCTER (K003187) - FDA 510(k) Clearance

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

K003187 · Auto/Cath Vascular Access, Inc. · General Hospital
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May 2001
Decision
222d
Days
Class 2
Risk

K003187 is an FDA 510(k) clearance for the VACUCATH I.V. CATHETER INTRODUCTER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Auto/Cath Vascular Access, Inc. (Lake Forest, US). The FDA issued a Cleared decision on May 21, 2001 after a review of 222 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Auto/Cath Vascular Access, Inc. devices

Submission Details

510(k) Number K003187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2000
Decision Date May 21, 2001
Days to Decision 222 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
93d slower than avg
Panel avg: 129d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 116
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K003187.
BD CAREFLOW CENTRAL VENOUS CATHETER
K033500 · Becton, Dickinson & CO · Jan 2004
SPECTRUM SILICONE CATHETER
K021557 · Cook, Inc. · May 2003
TRIPLE LUMEN CENTRAL VENOUS CATHETER
K013182 · Cook, Inc. · Jul 2002
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 2001
DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-
K010034 · Cook, Inc. · Jan 2001
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
K003245 · Baxter Healthcare Corp · Dec 2000