Cleared Traditional

K130483 - BOEHRINGER GASTRIC SIZING TUBE

K130483 is an FDA 510(k) clearance for BOEHRINGER GASTRIC SIZING TUBE, manufactured by Boehringer Laboratories, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K130483 · Boehringer Laboratories, LLC · Gastroenterology & Urology device
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Mar 2013
Decision
31d
Days
Class 2
Risk

K130483 is an FDA 510(k) clearance for the BOEHRINGER GASTRIC SIZING TUBE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Boehringer Laboratories, LLC (Phoenixville, US). The FDA issued a Cleared decision on March 28, 2013 after a review of 31 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 Boehringer Laboratories, LLC devices

FDA 510(k) Submission Details - K130483

510(k) Number K130483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2013
Decision Date March 28, 2013
Days to Decision 31 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 131d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 516
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K130483.
MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES
K122653 · Kimberly Clark Corporation · Jun 2013
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
K123716 · Applied Medical Technology, Inc. · Apr 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
K123804 · Hollister, Inc. · Apr 2013
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR)
K123659 · Actuated Medical, Inc. · Dec 2012
LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON
K122030 · Degania Silicone , Ltd. · Sep 2012
TUBECLEAR
K121571 · Actuated Medical, Inc. · Jun 2012

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.