Cleared Traditional

MPS ACACIA ENTERAL FEEDING TUBE (K080328) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080328 · Mps Acacia · Gastroenterology & Urology device
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May 2008
Decision
97d
Days
Class 2
Risk

K080328 is an FDA 510(k) clearance for the MPS ACACIA ENTERAL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Mps Acacia (Brea, US). The FDA issued a Cleared decision on May 14, 2008 after a review of 97 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 Mps Acacia devices

Submission Details

510(k) Number K080328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2008
Decision Date May 14, 2008
Days to Decision 97 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
33d faster than avg
Panel avg: 130d · This submission: 97d
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 143
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K080328.
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
WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBE
K043203 · Wilson-Cook Medical, Inc. · May 2005