Cleared Traditional

K853384 - E-Z-EM GASTRIC LAVAGE CATHETER

K853384 is the FDA 510(k) clearance for E-Z-EM GASTRIC LAVAGE CATHETER by E-Z-Em, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K853384 · E-Z-Em, Inc. · Gastroenterology & Urology device
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Nov 1985
Decision
85d
Days
Class 2
Risk

K853384 is an FDA 510(k) clearance for the E-Z-EM GASTRIC LAVAGE CATHETER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by E-Z-Em, Inc. (Westbury, US). The FDA issued a Cleared decision on November 5, 1985 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 E-Z-Em, Inc. devices

Submission Details

510(k) Number K853384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date November 05, 1985
Days to Decision 85 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
45d faster than avg
Panel avg: 130d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 - KNT Tubes, Gastrointestinal (and Accessories)

All 281
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K853384.
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986
COLOSHIELD KIT
K855121 · Deknatel, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985
COONS GASTROSTICK SYSTEM
K852552 · Medi-Tech, Inc. · Oct 1985
FEEDING UNITS & TUBES
K853288 · I M, Inc. · Oct 1985
ENDO-TUBE
K850664 · Biosearch Medical Products, Inc. · Jun 1985