Cleared Traditional

K822087 - DIA SCOPE

K822087 is the FDA 510(k) clearance for DIA SCOPE by Exitec, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K822087 · Exitec, Inc. · Gastroenterology & Urology device
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Nov 1982
Decision
127d
Days
Class 2
Risk

K822087 is an FDA 510(k) clearance for the DIA SCOPE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Exitec, Inc. (Walker, US). The FDA issued a Cleared decision on November 17, 1982 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Exitec, Inc. devices

Submission Details

510(k) Number K822087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1982
Decision Date November 17, 1982
Days to Decision 127 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
3d faster than avg
Panel avg: 130d · This submission: 127d
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 289
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K822087.
TOP-FILL BAG
K831169 · Biosearch Medical Products, Inc. · Apr 1983
ARGYLE SILICONE SALEM SUMP TUBE
K830710 · Sherwood Medical Co. · Mar 1983
NEEDLE CATHETER JEJUNOSTOMY KIT
K830119 · Biosearch Medical Products, Inc. · Jan 1983
TRAVASORB NASOGASTRIC NASOINTESTINAL
K823082 · Travenol Laboratories, S.A. · Nov 1982
FACE SHIELDS
K822004 · Kelleher Corp. · Oct 1982
PEDI-TUBE PEDIATRIC FEEDING TUBE
K822875 · Biosearch Medical Products, Inc. · Oct 1982