Cleared Traditional

K820442 - ARGYLE INDWELL FEEDING TUBE

K820442 is the FDA 510(k) clearance for ARGYLE INDWELL FEEDING TUBE by Sherwood Medical Co.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K820442 · Sherwood Medical Co. · Gastroenterology & Urology device

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Mar 1982

Decision

20d

Days

Class 2

Risk

K820442 is an FDA 510(k) clearance for the ARGYLE INDWELL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1982 after a review of 20 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 Sherwood Medical Co. devices

Submission Details

510(k) Number	K820442 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 18, 1982
Decision Date	March 10, 1982
Days to Decision	20 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

110d faster than avg

Panel avg: 130d · This submission: 20d

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 257

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K820442.

CONPHAR SILICONE FEEDING TUBE

K821825 · Conphar, Inc. · Aug 1982

AM. PH. STERILE FEEDING TUBE

K820420 · American Pharmaseal Div. Ahsc · Mar 1982

ARGYLE PVC FEEDING TUBE

K820441 · Sherwood Medical Co. · Mar 1982

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

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 K820442

Sherwood Medical Co.

Mchenry, IL · US

Regulatory profile

191 submissions 177 cleared

93% 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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