Cleared Special

ReShape Calibration Tubes (B-2032, B-2036, B-2040) (K241039) - FDA 510(k) Clearance

Also marketed or referenced as:
ReShape Calibration Tubes (B-2017) Gastric Balloon Suction Catheter (B-2020)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K241039 · Reshape Lifesciences · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
30d
Days
Class 2
Risk

K241039 is an FDA 510(k) clearance for the ReShape Calibration Tubes (B-2032, B-2036, B-2040). Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Reshape Lifesciences (Irvine, US). The FDA issued a Cleared decision on May 16, 2024 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 Reshape Lifesciences devices

Submission Details

510(k) Number K241039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2024
Decision Date May 16, 2024
Days to Decision 30 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
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 142
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K241039.
CORGRIP* SR NG/NI Tube Retention System
K241185 · Avanos Medical, Inc. · Oct 2024
CORTRAK* 2 Enteral Access System (20-0950)
K240965 · Avanos Medical, Inc. · Jun 2024
Stylus
K233591 · Degania Silicone , Ltd. · May 2024
ViSiGi LUX (5332)
K234033 · Boehringer Laboratories, LLC · May 2024
Enteral Feeding Sets
K240039 · Hangzhou Primecare Medical Co., Ltd. · Apr 2024
Endolumik Gastric Calibration Tube M Series (EGCT36M)
K240069 · Endolumik · Feb 2024