Cleared Traditional

K901130 - ENTERA-FLO FEEDING TUBE

K901130 is an FDA 510(k) clearance for ENTERA-FLO FEEDING TUBE, manufactured by Fresenius Pharma. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K901130 · Fresenius Pharma · Gastroenterology & Urology device
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Jun 1990
Decision
81d
Days
Class 2
Risk

K901130 is an FDA 510(k) clearance for the ENTERA-FLO FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Fresenius Pharma (New Brunswick, US). The FDA issued a Cleared decision on June 1, 1990 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fresenius Pharma devices

FDA 510(k) Submission Details - K901130

510(k) Number K901130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date June 01, 1990
Days to Decision 81 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 130d · This submission: 81d
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 K901130.
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
FRENTA(R) DUO-SET
K895246 · Delmed, Inc. · May 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