Cleared Traditional

K800507 - FEEDING TUBES

K800507 is the FDA 510(k) clearance for FEEDING TUBES by Medi-Craft , Ltd.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K800507 · Medi-Craft , Ltd. · Gastroenterology & Urology device
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Apr 1980
Decision
35d
Days
Class 2
Risk

K800507 is an FDA 510(k) clearance for the FEEDING TUBES. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medi-Craft , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 35 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 Medi-Craft , Ltd. devices

Submission Details

510(k) Number K800507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1980
Decision Date April 08, 1980
Days to Decision 35 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
95d faster than avg
Panel avg: 130d · This submission: 35d
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 206
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K800507.
ENTRI NASOGASTRIC FEEDING TUBE
K801498 · Biosearch Medical Products, Inc. · Jul 1980
NASO-GARD NASOGASTRIC TUBE HOLDER
K801511 · Howmedica Corp. · Jul 1980
ENTERIC FEEDING TUBE W/SEGM. FLEX. WT.
K801558 · Biosearch Medical Products, Inc. · Jul 1980
CONPHAR STOMACH TUBE-STERILE-X-RAY
K791250 · Conphar, Inc. · Aug 1979
CONPHAR FEEDING TUBE-STERILE
K791257 · Conphar, Inc. · Aug 1979
CONPHAR RECTAL TUBE-STERILE
K791268 · Conphar, Inc. · Aug 1979