Cleared Special

K091340 - THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350

K091340 is an FDA 510(k) clearance for THROUGH THE -PEG (TTP) JEJUNAL FEEDING ..., manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Special 510(k) pathway after a 34-day FDA review.

K091340 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
34d
Days
Class 2
Risk

K091340 is an FDA 510(k) clearance for the THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M.... Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on June 9, 2009 after a review of 34 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.

FDA 510(k) Submission Details - K091340

510(k) Number K091340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 06, 2009
Decision Date June 09, 2009
Days to Decision 34 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
97d faster than avg
Panel avg: 131d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

FPD Device Classification - Class 2, Special Controls

Product Code FPD Tube, Feeding
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 - FPD Tube, Feeding

All 56
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K091340.
GUARDIAN CONNECTION
K101214 · Maulin Medical, LLC · Jul 2010
ORAL/ENTERAL SYRINGES
K100099 · Philips Children'S Medical Ventures · Jun 2010
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
K100526 · Kentec Medical, Inc. · Apr 2010
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
K083776 · Corpak Medsystems · Mar 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
K083791 · Corpak Medsystems · Mar 2009
CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
K083786 · Corpak Medsystems · Feb 2009
K091340 · THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
Download PDF FDA Summary Boston Scientific Corp