Cleared Traditional

K884325 - SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUF...

K884325 is an FDA 510(k) clearance for SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUF..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K884325 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 1989
Decision
193d
Days
Class 2
Risk

K884325 is an FDA 510(k) clearance for the SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sandy, US). The FDA issued a Cleared decision on April 25, 1989 after a review of 193 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K884325

510(k) Number K884325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date April 25, 1989
Days to Decision 193 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 129d · This submission: 193d
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 278
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K884325.
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · Critikon Company, LLC · Nov 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989
TERUMO SURFLO(R) I.V. CATHETER
K891087 · Terumo Medical Corp. · Jun 1989
CATH-FINDER SYSTEM
K884701 · Pharmacia Deltec, Inc. · Feb 1989
LANDMARK VENOUS ACCESS DRIVE (ADDITIONAL SIZES)
K883980 · Menlo Care, Inc. · Dec 1988
NEOSOFT UMBILICAL VESSEL CATHETER
K883866 · Menlo Care, Inc. · Nov 1988