Cleared Traditional

K811061 - AUTOMATED GASTRIC LAVAGE

K811061 is the FDA 510(k) clearance for AUTOMATED GASTRIC LAVAGE by Emergency Medicine. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K811061 · Emergency Medicine · Gastroenterology & Urology device
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Jun 1981
Decision
67d
Days
Class 2
Risk

K811061 is an FDA 510(k) clearance for the AUTOMATED GASTRIC LAVAGE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Emergency Medicine (Library, US). The FDA issued a Cleared decision on June 23, 1981 after a review of 67 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 Emergency Medicine devices

Submission Details

510(k) Number K811061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1981
Decision Date June 23, 1981
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 130d · This submission: 67d
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 291
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K811061.
CARTMILL/BARRY FEEDING TUBE
K812427 · Impra, Inc. · Sep 1981
ENTER-A1 ENTERIC FEEDING TUBE
K812279 · Medi-Tech, Inc. · Aug 1981
ENTRI ENTERNAL FEEDING SET
K811683 · Biosearch Medical Products, Inc. · Jul 1981
ARROW NEEDLE-CATHETER JEJUNOSTOMY KIT
K810979 · Arrow Intl., Inc. · Jun 1981
ENTERNAL PUMP SET W/INTEGRAL CONTAINER
K810996 · Abbott Laboratories · Apr 1981
KANGAROO NASOGASTRIC FEEDING TUBE
K810854 · Chesebrough-Pond'S U.S.A. Co. · Apr 1981