Cleared Traditional

K861725 - INTRACATH INTRAVENOUS CATHETER PLACEMEN...

K861725 is the FDA 510(k) clearance for INTRACATH INTRAVENOUS CATHETER PLACEMEN... by Parke-Davis Co.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K861725 · Parke-Davis Co. · General Hospital
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Dec 1986
Decision
212d
Days
Class 2
Risk

K861725 is an FDA 510(k) clearance for the INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Parke-Davis Co. (Rochester, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 212 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 Parke-Davis Co. devices

Submission Details

510(k) Number K861725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date December 04, 1986
Days to Decision 212 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
83d slower than avg
Panel avg: 129d · This submission: 212d
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 K861725.
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949 · Quinton, Inc. · Feb 1987
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · Arrow Intl., Inc. · Dec 1986
POLYCATH-H CATHETER
K854308 · Abbott Laboratories · Apr 1986
TERUMO SURFLO ETFE I.V. CATHETER
K854566 · Terumo Medical Corp. · Jan 1986
QUINTON INJECTION SEALING CAP
K844193 · Quinton, Inc. · May 1985