Cleared Traditional

K834480 - INJECTION CAP

K834480 is the FDA 510(k) clearance for INJECTION CAP by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Feb 1984
Decision
46d
Days
Class 2
Risk

K834480 is an FDA 510(k) clearance for the INJECTION CAP. 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 (Walker, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 46 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K834480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date February 04, 1984
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 273
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K834480.
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
DESERET SUBCLAVIAN JUGULAR CATH-SET
K833091 · Warner-Lambert Co. · Nov 1983
DESERET ANGIO-GUIDE LARGE VEIN CATH.
K833092 · Warner-Lambert Co. · Nov 1983
INTRACATH INTRAVENOUS CATHETER UNIT
K833135 · Parke-Davis Co. · Nov 1983