Cleared Traditional

K895330 - 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA

K895330 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 244-day FDA review.

K895330 · Delmed, Inc. · Gastroenterology & Urology device
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May 1990
Decision
244d
Days
Class 2
Risk

K895330 is an FDA 510(k) clearance for the 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA. 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 May 2, 1990 after a review of 244 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 Delmed, Inc. devices

FDA 510(k) Submission Details - K895330

510(k) Number K895330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1989
Decision Date May 02, 1990
Days to Decision 244 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
113d slower than avg
Panel avg: 131d · This submission: 244d
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 K895330.
GASTROINTESTINAL TUBES AND ACCESSORIES
K901023 · Medline Industries, Inc. · Jul 1990
ACKRAD MPR DRAINAGE CATHETER SET
K901574 · Ackrad Laboratories · Jun 1990
FRENTA(R) DUO-SET
K895246 · Delmed, Inc. · May 1990
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
K895366 · Fresenius USA, Inc. · May 1990
ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU
K895696 · Delmed, Inc. · May 1990
ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
K895919 · Delmed, Inc. · May 1990