Cleared Traditional

K822096 - CHEMOTHERAPY INFUSION CATHETER

K822096 is an FDA 510(k) clearance for CHEMOTHERAPY INFUSION CATHETER, manufactured by American Heyer Schulte. The device is a Class 1 General & Plastic Surgery device with product code JCY cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K822096 · American Heyer Schulte · General & Plastic Surgery device
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Apr 1983
Decision
270d
Days
Class 1
Risk

K822096 is an FDA 510(k) clearance for the CHEMOTHERAPY INFUSION CATHETER. Classified as Catheter, Infusion (product code JCY), Class I - General Controls.

Submitted by American Heyer Schulte (Walker, US). The FDA issued a Cleared decision on April 12, 1983 after a review of 270 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Heyer Schulte devices

FDA 510(k) Submission Details - K822096

510(k) Number K822096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1982
Decision Date April 12, 1983
Days to Decision 270 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 115d · This submission: 270d
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 8
Devices cleared under the same product code (JCY) and FDA review panel - the closest regulatory comparables to K822096.
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
SILICONE ELASTOMER INFUSION CATHETER
K813606 · Quest Medical, Inc. · Jan 1982
JELCO & KVO CATHETER PLACEMENT UNIT
K791372 · Jelco Laboratories · Sep 1979
CATHETER, CEBTRAL VENOUS, 2N1501
K771861 · Travenol Laboratories, S.A. · Nov 1977