Cleared Traditional

K061432 - HOSPIRA ENTERAL FEEDING SET, MODEL 20640

K061432 is an FDA 510(k) clearance for HOSPIRA ENTERAL FEEDING SET, manufactured by Hospira, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K061432 · Hospira, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Sep 2006
Decision
110d
Days
Class 2
Risk

K061432 is an FDA 510(k) clearance for the HOSPIRA ENTERAL FEEDING SET, MODEL 20640. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Hospira, Inc. (Lake Forest, US). The FDA issued a Cleared decision on September 11, 2006 after a review of 110 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 Hospira, Inc. devices

FDA 510(k) Submission Details - K061432

510(k) Number K061432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2006
Decision Date September 11, 2006
Days to Decision 110 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 131d · This submission: 110d
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 435
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K061432.
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · Boston Scientific Corporation · Dec 2007
GASTROSTOMY REPLACEMENT TUBE, MODEL 253
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BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007
ENTAKE STANDARD AND SAFETY PEG SYSTEM
K061021 · Conmedcorp · Apr 2006
PEDIATRIC FEEDING TUBE
K052903 · Promedic, Inc. · Nov 2005
SMALL INTESTINAL VIDEOSCOPE SYSTEM
K051551 · Olympus Medical Systems Corporation · Jun 2005