Cleared Special

K021991 - MAGNAFLOW MAGNETICALLY GUIDED ENTERAL F...

K021991 is the FDA 510(k) clearance for MAGNAFLOW MAGNETICALLY GUIDED ENTERAL F... by Syncro Medical Innovations, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KNT) cleared through the Special 510(k) pathway after a 30-day FDA review.

K021991 · Syncro Medical Innovations, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
30d
Days
Class 2
Risk

K021991 is an FDA 510(k) clearance for the MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Syncro Medical Innovations, Inc. (Macon, US). The FDA issued a Cleared decision on July 18, 2002 after a review of 30 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 Syncro Medical Innovations, Inc. devices

Submission Details

510(k) Number K021991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date July 18, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K021991.
MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT
K030855 · Boston Scientific Corp · Apr 2003
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521
K022648 · Boston Scientific Corp · Sep 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp · Aug 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · Boston Scientific Corp · Jul 2002
RUSCH MILLER-ABBOTT TUBE
K010797 · Rusch Intl. · Feb 2002
RUSCH CANTOR TUBE
K010798 · Rusch Intl. · Feb 2002