Cleared Traditional

K101214 - GUARDIAN CONNECTION

K101214 is an FDA 510(k) clearance for GUARDIAN CONNECTION, manufactured by Maulin Medical, LLC. The device is a Class 2 Gastroenterology & Urology device with product code FPD cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K101214 · Maulin Medical, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
84d
Days
Class 2
Risk

K101214 is an FDA 510(k) clearance for the GUARDIAN CONNECTION. Classified as Tube, Feeding (product code FPD), Class II - Special Controls.

Submitted by Maulin Medical, LLC (Pueblo West, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maulin Medical, LLC devices

FDA 510(k) Submission Details - K101214

510(k) Number K101214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2010
Decision Date July 23, 2010
Days to Decision 84 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
47d faster than avg
Panel avg: 131d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 43
Devices cleared under the same product code (FPD) and FDA review panel - the closest regulatory comparables to K101214.
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K100163 · Vygon Corp. · Oct 2011
VR MEDICAL ENTERAL ORAL SYRINGE
K110853 · Vr Medical · May 2011
MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES
K100700 · Benlan, Inc. · Dec 2010
ORAL/ENTERAL SYRINGES
K100099 · Philips Children'S Medical Ventures · Jun 2010
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE
K100526 · Kentec Medical, Inc. · Apr 2010
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp · Jun 2009