Cleared Traditional

Standard Tapered Bougie, 38 Fr. (K222085) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222085 · Standard Bariatrics, Inc. · Gastroenterology & Urology device
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Oct 2022
Decision
108d
Days
Class 2
Risk

K222085 is an FDA 510(k) clearance for the Standard Tapered Bougie, 38 Fr.. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Standard Bariatrics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 31, 2022 after a review of 108 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Standard Bariatrics, Inc. devices

Submission Details

510(k) Number K222085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2022
Decision Date October 31, 2022
Days to Decision 108 days
Submission Type Traditional
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
22d faster than avg
Panel avg: 130d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 141
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K222085.
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880 · Endolumik, Inc. · Mar 2023
ReShape Calibration Tubes
K230131 · Reshape Lifesciences · Feb 2023
hygh-tec drainage
K221400 · Creative Balloons GmbH · Feb 2023
DoubleChek DC-1001
K212316 · Nasogastric Feeding Solutions, Ltd. · Sep 2022
Gastrointestinal Boundary Identifier (GIBI HD)
K221898 · Reshape Lifesciences · Jul 2022
Gastric Lightguide (GLG)
K212407 · Naser Dib Gabinet Lekarksi Nasmed · Jul 2022