Cleared Special

K080340 - COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG

K080340 is an FDA 510(k) clearance for COMPAT DUALFLO ENTERAL DELIVERY PUMP SE..., manufactured by Novartis Nutrition Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Special 510(k) pathway after a 26-day FDA review.

K080340 · Novartis Nutrition Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2008
Decision
26d
Days
Class 2
Risk

K080340 is an FDA 510(k) clearance for the COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1.... Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Novartis Nutrition Corp. (Minneapolis, US). The FDA issued a Cleared decision on March 5, 2008 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Novartis Nutrition Corp. devices

FDA 510(k) Submission Details - K080340

510(k) Number K080340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2008
Decision Date March 05, 2008
Days to Decision 26 days
Submission Type Special
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
105d faster than avg
Panel avg: 131d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 511
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K080340.
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598 · C.R. Bard, Inc. · Jun 2008
MPS ACACIA ENTERAL FEEDING TUBE
K080328 · Mps Acacia · May 2008
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
K073034 · Applied Medical Technology, Inc. · Mar 2008
ENTERAL FEEDING SPIKE ADAPTER
K072652 · Cedic S.R.L. · Jan 2008
NON-IV ADAPTER FOR INFANT NG TUBE
K072756 · Promedic, Inc. · Dec 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · Boston Scientific Corporation · Dec 2007