Cleared Traditional

K853288 - FEEDING UNITS & TUBES

K853288 is an FDA 510(k) clearance for FEEDING UNITS & TUBES, manufactured by I M, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K853288 · I M, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
38d
Days
Class 2
Risk

K853288 is an FDA 510(k) clearance for the FEEDING UNITS & TUBES. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 38 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.

FDA 510(k) Submission Details - K853288

510(k) Number K853288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1985
Decision Date October 04, 1985
Days to Decision 38 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
93d faster than avg
Panel avg: 131d · This submission: 38d
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 651
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K853288.
88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT
K853353 · Superior Healthcare Group, Inc. · Nov 1985
E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY
K852535 · Tri-Med Specialties, Inc. · Oct 1985
COONS GASTROSTICK SYSTEM
K852552 · Medi-Tech, Inc. · Oct 1985
ENTERAL FEEDING BAG, 1000 ML, & TUBING SET
K851975 · Venusa , Ltd. · Sep 1985
ENTERAL FEEDING CONTAINER
K852966 · Empire Industries, Inc. · Aug 1985
P.A. ENTERAL FEEDING BAG 1100
K853309 · Pa Medical Corp. · Aug 1985
K853288 · FEEDING UNITS & TUBES
Download PDF I M, Inc.