Cleared Traditional

K834255 - PBC SCALP VEIN SET

K834255 is an FDA 510(k) clearance for PBC SCALP VEIN SET, manufactured by Philadelphia Biologics Center. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K834255 · Philadelphia Biologics Center · General Hospital
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Mar 1984
Decision
96d
Days
Class 2
Risk

K834255 is an FDA 510(k) clearance for the PBC SCALP VEIN SET. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Philadelphia Biologics Center (Walker, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 96 days - within the typical 510(k) review window.

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 Philadelphia Biologics Center devices

FDA 510(k) Submission Details - K834255

510(k) Number K834255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1983
Decision Date March 12, 1984
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
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 429
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K834255.
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840183 · Parke-Davis Co. · Mar 1984
DESERET MULTILUMEN SUBCLAVIAN JUGULAR
K840355 · Parke-Davis Co. · Mar 1984
DESERET CENTRAL VENOUS CATHETER
K840862 · Parke-Davis Co. · Mar 1984
DESERET NEONATAL CATHETER SET
K834393 · Parke-Davis Co. · Feb 1984
INJECTION CAP
K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984
CENTRACATH #130,135 & 137-HEMOCATH #
K833079 · Exco, Inc. · Dec 1983