Cleared Traditional

THE KEOFEED STOMACH TUBE (K812507) - FDA 510(k) Clearance

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

K812507 · Hedeco · Gastroenterology & Urology device

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Sep 1981

Decision

13d

Days

Class 2

Risk

K812507 is an FDA 510(k) clearance for the THE KEOFEED STOMACH TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hedeco (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981 after a review of 13 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 Hedeco devices

Submission Details

510(k) Number	K812507 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 01, 1981
Decision Date	September 14, 1981
Days to Decision	13 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

117d faster than avg

Panel avg: 130d · This submission: 13d

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 124

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K812507.

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 K812507

Hedeco

Mchenry, IL · US

Regulatory profile

4 submissions 4 cleared

100% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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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.

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