Cleared Traditional

K943675 - ENTERAL DELIVERY SETS WITH HYDRATION PORT

K943675 is an FDA 510(k) clearance for ENTERAL DELIVERY SETS WITH HYDRATION PORT, manufactured by Clintec Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K943675 · Clintec Technologies, Inc. · Gastroenterology & Urology device
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Dec 1994
Decision
157d
Days
Class 2
Risk

K943675 is an FDA 510(k) clearance for the ENTERAL DELIVERY SETS WITH HYDRATION PORT. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Clintec Technologies, Inc. (Deerfiels, US). The FDA issued a Cleared decision on December 30, 1994 after a review of 157 days - an extended review 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: 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 Clintec Technologies, Inc. devices

FDA 510(k) Submission Details - K943675

510(k) Number K943675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1994
Decision Date December 30, 1994
Days to Decision 157 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 130d · This submission: 157d
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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K943675.
FLEXIFLO SIX ENTERAL NUTRITION PUMP SET
K943240 · Abbott Laboratories · Apr 1995
FLEXIFLO NASOENTERIC FEEDING TUBE
K922217 · Abbott Laboratories · Mar 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · Abbott Laboratories · Jan 1995
VANSONNENBERG GASTROSTOMY CATHETER
K924850 · Boston Scientific Corp · Dec 1994
KLEIN RECTAL TAMPNADE BALLOON
K933842 · Cook Urological, Inc. · Sep 1994
GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS
K935198 · Lake Region Mfg., Inc. · Sep 1994