Cleared Traditional

K854616 - ENTERAL FEEDING BAG

K854616 is an FDA 510(k) clearance for ENTERAL FEEDING BAG, manufactured by Medovations, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K854616 · Medovations, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1986
Decision
66d
Days
Class 2
Risk

K854616 is an FDA 510(k) clearance for the ENTERAL FEEDING BAG. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medovations, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 23, 1986 after a review of 66 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 Medovations, Inc. devices

FDA 510(k) Submission Details - K854616

510(k) Number K854616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date January 23, 1986
Days to Decision 66 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
65d faster than avg
Panel avg: 131d · This submission: 66d
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 469
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K854616.
COMPAT ENTERAL DELIVERY SYSTEMS
K855098 · Sandoz Nutrition · Apr 1986
INFLATOR/DEFLATOR PISTON SYRINGE
K860589 · Microvasive · Apr 1986
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
K860285 · Vygon Corp. · Feb 1986
DYNAFEED ENTERAL PUMP FEED BAG
K860075 · Medline Industries, Inc. · Jan 1986
COLOSHIELD KIT
K855121 · Deknatel, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985