Cleared Traditional

JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL (K853701) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853701 · Critikon Company, LLC · General Hospital
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Oct 1985
Decision
43d
Days
Class 2
Risk

K853701 is an FDA 510(k) clearance for the JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Critikon Company, LLC (Southington, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 43 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 Critikon Company, LLC devices

Submission Details

510(k) Number K853701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1985
Decision Date October 17, 1985
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 139
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K853701.
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K854566 · Terumo Medical Corp. · Jan 1986
QUINTON INJECTION SEALING CAP
K844193 · Quinton, Inc. · May 1985
QUINTON WHITE SEALING CAP
K850369 · Quinton, Inc. · Feb 1985
LUER LOCKING ADAPTER(MATERIAL CHANGE)
K840815 · Quinton, Inc. · Nov 1984