Cleared Traditional

K896806 - CATHETER PLUG/PROTECTOR

K896806 is an FDA 510(k) clearance for CATHETER PLUG/PROTECTOR, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K896806 · Westmark, Sterile Packing Systems, Inc. (Sps) · Gastroenterology & Urology device
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Feb 1990
Decision
87d
Days
Class 2
Risk

K896806 is an FDA 510(k) clearance for the CATHETER PLUG/PROTECTOR. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on February 26, 1990 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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 Westmark, Sterile Packing Systems, Inc. (Sps) devices

FDA 510(k) Submission Details - K896806

510(k) Number K896806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date February 26, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 131d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 30
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K896806.
MENTOR INFUSION LINE
K912919 · Mentor Corp. · Dec 1991
FLEXI-TRAK(TM) ANCHORING DEVICE
K905128 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS
K900031 · Porges Corp. · Mar 1990
TECNOL CATHETER LEG STRAP
K882641 · Tecnol New Jersey Wound Care, Inc. · Jul 1988
DEFLECTING GUIDE WIRE
K833242 · Van-Tec, Inc. · Oct 1983
SAFEED DISP. PLASTIC CATHETER
K771212 · Terumo America, Inc. · Sep 1977