Cleared Traditional

K800815 - ENTERAL & NASOGASTRIC SOL. ADMIN. SET

K800815 is an FDA 510(k) clearance for ENTERAL & NASOGASTRIC SOL. ADMIN. SET, manufactured by G.D. Searle and Co.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K800815 · G.D. Searle and Co. · Gastroenterology & Urology device
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Jul 1980
Decision
101d
Days
Class 2
Risk

K800815 is an FDA 510(k) clearance for the ENTERAL & NASOGASTRIC SOL. ADMIN. SET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 101 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 G.D. Searle and Co. devices

FDA 510(k) Submission Details - K800815

510(k) Number K800815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1980
Decision Date July 21, 1980
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

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 301
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K800815.
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
TUBE FEEDING CONTAINER 1500 ML DISPOSE.
K800955 · The Healthcare Group Laboratories, Inc. · May 1980
CONPHAR STOMACH TUBE-STERILE-X-RAY
K791250 · Conphar, Inc. · Aug 1979
CONPHAR FEEDING TUBE-STERILE
K791257 · Conphar, Inc. · Aug 1979