Cleared Traditional

AUTOMATED GASTRIC LAVAGE (K811061) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811061 · Emergency Medicine · Gastroenterology & Urology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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 125

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K811061.

ARGYLE DUO-TUBE

K822631 · Sherwood Medical Co. · Sep 1982

ARGYLE PVC FEEDING TUBE

K820441 · Sherwood Medical Co. · Mar 1982

ARGYLE INDWELL FEEDING TUBE

K820442 · Sherwood Medical Co. · Mar 1982

ENTERNAL PUMP SET W/INTEGRAL CONTAINER

K810996 · Abbott Laboratories · Apr 1981

ARGYLE SALEM SUMP TUBE

K810156 · Sherwood Medical Co. · Mar 1981

NASO-GARD NASOGASTRIC TUBE HOLDER

K801511 · Howmedica Corp. · Jul 1980

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K811061

Emergency Medicine

Library, PA · US

JOSEPH P RUDOLPH

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,218

Regulatory data since 1976

FDA monthly sync Active