Cleared Traditional

K072652 - ENTERAL FEEDING SPIKE ADAPTER

K072652 is the FDA 510(k) clearance for ENTERAL FEEDING SPIKE ADAPTER by Cedic S.R.L.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K072652 · Cedic S.R.L. · Gastroenterology & Urology device
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Jan 2008
Decision
120d
Days
Class 2
Risk

K072652 is an FDA 510(k) clearance for the ENTERAL FEEDING SPIKE ADAPTER. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Cedic S.R.L. (Peschiera Borromeo, IT). The FDA issued a Cleared decision on January 18, 2008 after a review of 120 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 Cedic S.R.L. devices

Submission Details

510(k) Number K072652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2007
Decision Date January 18, 2008
Days to Decision 120 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 130d · This submission: 120d
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 253
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K072652.
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739 · Boston Scientific Corp · Dec 2008
ENTERAL ONLY EXTENSION SET
K082654 · Respironics, Inc. · Nov 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598 · C.R. Bard, Inc. · Jun 2008
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · Boston Scientific Corporation · Dec 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
K061432 · Hospira, Inc. · Sep 2006