Cleared Traditional

K901134 - ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE

K901134 is an FDA 510(k) clearance for ENTERA-FLO REPLACEMENT GASTROSTOMY 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 100-day FDA review.

K901134 · Fresenius Pharma · Gastroenterology & Urology device
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Jun 1990
Decision
100d
Days
Class 2
Risk

K901134 is an FDA 510(k) clearance for the ENTERA-FLO REPLACEMENT GASTROSTOMY 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 20, 1990 after a review of 100 days - within the typical 510(k) review window.

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 Fresenius Pharma devices

FDA 510(k) Submission Details - K901134

510(k) Number K901134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 12, 1990
Decision Date June 20, 1990
Days to Decision 100 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
30d faster than avg
Panel avg: 130d · This submission: 100d
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 K901134.
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