Cleared Traditional

K813606 - SILICONE ELASTOMER INFUSION CATHETER

K813606 is an FDA 510(k) clearance for SILICONE ELASTOMER INFUSION CATHETER, manufactured by Quest Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code JCY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K813606 · Quest Medical, Inc. · General & Plastic Surgery device
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Jan 1982
Decision
20d
Days
Class 1
Risk

K813606 is an FDA 510(k) clearance for the SILICONE ELASTOMER INFUSION CATHETER. Classified as Catheter, Infusion (product code JCY), Class I - General Controls.

Submitted by Quest Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 Quest Medical, Inc. devices

FDA 510(k) Submission Details - K813606

510(k) Number K813606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1981
Decision Date January 18, 1982
Days to Decision 20 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

JCY Device Classification - Class 1, General Controls

Product Code JCY Catheter, Infusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JCY Catheter, Infusion

All 7
Devices cleared under the same product code (JCY) and FDA review panel - the closest regulatory comparables to K813606.
TRIPLE LUMEN INFUSIONCATHETERS-
K834615 · Medical Components, Inc. · Feb 1984
SILCATH CENTRAL CATHETER TRAY W/18 GA
K831453 · Argon Medical Corp. · Jul 1983
SILCATH CENTRAL CATHETER TRAY SIZE-
K831451 · Argon Medical Corp. · Jun 1983
JELCO & KVO CATHETER PLACEMENT UNIT
K791372 · Jelco Laboratories · Sep 1979
CATHETER, CEBTRAL VENOUS, 2N1501
K771861 · Travenol Laboratories, S.A. · Nov 1977
CATHETER, INTRAVASCULAR (ARGYLE IV SK)
K760760 · Sherwood Medical Industries · Dec 1976