Cleared Traditional

K860075 - DYNAFEED ENTERAL PUMP FEED BAG

K860075 is the FDA 510(k) clearance for DYNAFEED ENTERAL PUMP FEED BAG by Medline Industries, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K860075 · Medline Industries, Inc. · Gastroenterology & Urology device
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Jan 1986
Decision
16d
Days
Class 2
Risk

K860075 is an FDA 510(k) clearance for the DYNAFEED ENTERAL PUMP FEED BAG. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on January 23, 1986 after a review of 16 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K860075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1986
Decision Date January 23, 1986
Days to Decision 16 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
114d faster than avg
Panel avg: 130d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 252
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K860075.
TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)
K861618 · Travenol Laboratories, S.A. · Jul 1986
SCLEROTHERAPY INJECTION CATHETER
K860991 · Endovations · May 1986
XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
K860285 · Vygon Corp. · Feb 1986
COLOSHIELD KIT
K855121 · Deknatel, Inc. · Jan 1986
DYNAFEED
K854215 · Medline Industries, Inc. · Dec 1985
E-Z-EM GASTRIC LAVAGE CATHETER
K853384 · E-Z-Em, Inc. · Nov 1985