Cleared Traditional

K895329 - 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA

K895329 is an FDA 510(k) clearance for 600ML AND 1200ML ENTERAL BAG ADM. SET F..., manufactured by Delmed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 397-day FDA review.

K895329 · Delmed, Inc. · Gastroenterology & Urology device
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Oct 1990
Decision
397d
Days
Class 2
Risk

K895329 is an FDA 510(k) clearance for the 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Delmed, Inc. (New Brunswick, US). The FDA issued a Cleared decision on October 2, 1990 after a review of 397 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Delmed, Inc. devices

FDA 510(k) Submission Details - K895329

510(k) Number K895329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1989
Decision Date October 02, 1990
Days to Decision 397 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
266d slower than avg
Panel avg: 131d · This submission: 397d
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 406
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K895329.
FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT
K903325 · Abbott Laboratories · Nov 1990
WILSON-COOK VARICES TAMPONADE BALLOON CUFF
K902099 · Wilson-Cook Medical, Inc. · Nov 1990
ENTERAL PUMP SET WITH ENTERAL SPIKE
K895142 · Delmed, Inc. · Oct 1990
ENTERAL PUMP SET W/ENTERA-FLO SPIKE
K895650 · Delmed, Inc. · Oct 1990
MIC ANAL INCONTINENCE TUBE
K902684 · Medical Innovations Corp. · Sep 1990
DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE
K900324 · Biosearch Medical Products, Inc. · Aug 1990