Cleared Traditional

GASTRO VAGE SET FOR GASTRIC LAVAGE (K822228) - FDA 510(k) Clearance

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

K822228 · Ackrad Laboratories · Gastroenterology & Urology device

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Sep 1982

Decision

44d

Days

Class 2

Risk

K822228 is an FDA 510(k) clearance for the GASTRO VAGE SET FOR GASTRIC LAVAGE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Ackrad Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 9, 1982 after a review of 44 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 Ackrad Laboratories devices

Submission Details

510(k) Number	K822228 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 1982
Decision Date	September 09, 1982
Days to Decision	44 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

86d faster than avg

Panel avg: 130d · This submission: 44d

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 142

Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K822228.

ARGYLE MADEN SILICONE GASTROSTOMY TUBE

K830794 · Sherwood Medical Co. · May 1983

ARGYLE SILICONE SALEM SUMP TUBE

K830710 · Sherwood Medical Co. · Mar 1983

TRAVASORB NASOGASTRIC NASOINTESTINAL

K823082 · Travenol Laboratories, S.A. · Nov 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

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 K822228

Ackrad Laboratories

Mchenry, IL · US

Regulatory profile

42 submissions 41 cleared

98% 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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