Cleared Traditional

K821036 - ENTERNAL SOLUTION ADMIN. SET

K821036 is the FDA 510(k) clearance for ENTERNAL SOLUTION ADMIN. SET by Corpak Co.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K821036 · Corpak Co. · Gastroenterology & Urology device

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Apr 1982

Decision

13d

Days

Class 2

Risk

K821036 is an FDA 510(k) clearance for the ENTERNAL SOLUTION ADMIN. SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Corpak Co. (Walker, US). The FDA issued a Cleared decision on April 26, 1982 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 Corpak Co. devices

Submission Details

510(k) Number	K821036 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 13, 1982
Decision Date	April 26, 1982
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 209

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K821036.

PEDI-TUBE PEDIATRIC FEEDING TUBE

K822875 · Biosearch Medical Products, Inc. · Oct 1982

ARGYLE DUO-TUBE

K822631 · Sherwood Medical Co. · Sep 1982

CONPHAR SILICONE FEEDING TUBE

K821825 · Conphar, Inc. · Aug 1982

ARGYLE PVC FEEDING TUBE

K820441 · Sherwood Medical Co. · Mar 1982

ARGYLE INDWELL FEEDING TUBE

K820442 · Sherwood Medical Co. · Mar 1982

ENTRI ENTERNAL FEEDING SET

K811683 · Biosearch Medical Products, Inc. · Jul 1981

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 K821036

Corpak Co.

Walker, MI · US

Regulatory profile

21 submissions 20 cleared

95% 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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