Cleared Traditional

K033500 - BD CAREFLOW CENTRAL VENOUS CATHETER

K033500 is an FDA 510(k) clearance for BD CAREFLOW CENTRAL VENOUS CATHETER, manufactured by Becton, Dickinson & CO. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K033500 · Becton, Dickinson & CO · General Hospital
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Jan 2004
Decision
85d
Days
Class 2
Risk

K033500 is an FDA 510(k) clearance for the BD CAREFLOW CENTRAL VENOUS CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Sandy, US). The FDA issued a Cleared decision on January 29, 2004 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Becton, Dickinson & CO devices

FDA 510(k) Submission Details - K033500

510(k) Number K033500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2003
Decision Date January 29, 2004
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

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 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K033500.
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MODIFICATION TO V-CATH POLY PICC
K033853 · Hdc Corp. · Jan 2004
EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
K033250 · Edwards Lifesciences, LLC · Dec 2003
MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE
K032777 · Nipro Medical Corp. · Nov 2003