Cleared Traditional

K840324 - SILICONE SUMP DRAIN 20 & 40 FRENCH

K840324 is an FDA 510(k) clearance for SILICONE SUMP DRAIN 20 & 40 FRENCH, manufactured by Superior Plastic Products Corp.. The device is a Class 1 General & Plastic Surgery device with product code JCY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K840324 · Superior Plastic Products Corp. · General & Plastic Surgery device
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Apr 1984
Decision
91d
Days
Class 1
Risk

K840324 is an FDA 510(k) clearance for the SILICONE SUMP DRAIN 20 & 40 FRENCH. Classified as Catheter, Infusion (product code JCY), Class I - General Controls.

Submitted by Superior Plastic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 91 days - within the typical 510(k) review window.

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 Superior Plastic Products Corp. devices

FDA 510(k) Submission Details - K840324

510(k) Number K840324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date April 25, 1984
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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 K840324.
VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
K863982 · Vas-Cath of Canada , Ltd. · Oct 1986
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