Cleared Traditional

K833135 - INTRACATH INTRAVENOUS CATHETER UNIT

K833135 is the FDA 510(k) clearance for INTRACATH INTRAVENOUS CATHETER UNIT by Parke-Davis Co.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K833135 · Parke-Davis Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1983
Decision
68d
Days
Class 2
Risk

K833135 is an FDA 510(k) clearance for the INTRACATH INTRAVENOUS CATHETER UNIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 68 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 Parke-Davis Co. devices

Submission Details

510(k) Number K833135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1983
Decision Date November 21, 1983
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 144
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K833135.
QUINTON WHITE SEALING CAP
K850369 · Quinton, Inc. · Feb 1985
LUER LOCKING ADAPTER(MATERIAL CHANGE)
K840815 · Quinton, Inc. · Nov 1984
INJECTION CAP
K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984
INJECTION SEALING CAP 13791
K830541 · Quinton, Inc. · Aug 1983
WINGED CATHETER
K830765 · Abbott Laboratories · Mar 1983
TEFLON CANNULA
K822776 · Cardiac Pacemakers, Inc. · Nov 1982