Cleared Traditional

K895246 - FRENTA(R) DUO-SET

K895246 is an FDA 510(k) clearance for FRENTA DUO-SET, 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 254-day FDA review.

K895246 · Delmed, Inc. · Gastroenterology & Urology device
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May 1990
Decision
254d
Days
Class 2
Risk

K895246 is an FDA 510(k) clearance for the FRENTA(R) DUO-SET. 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 254 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 - K895246

510(k) Number K895246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date May 02, 1990
Days to Decision 254 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
123d slower than avg
Panel avg: 131d · This submission: 254d
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 K895246.
DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING SYSTEM
K900624 · Biosearch Medical Products, Inc. · Aug 1990
GASTROINTESTINAL TUBES AND ACCESSORIES
K901023 · Medline Industries, Inc. · Jul 1990
ACKRAD MPR DRAINAGE CATHETER SET
K901574 · Ackrad Laboratories · Jun 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
K895330 · 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