KNT · Class II · 21 CFR 876.5980

FDA Product Code KNT: Tubes, Gastrointestinal (and Accessories)

FDA product code KNT covers gastrointestinal tubes and accessories used for enteral feeding, gastric drainage, and bowel decompression.

These nasogastric, nasoenteric, and gastrostomy tubes are used to deliver nutrients and medications directly to the stomach or small intestine in patients who cannot eat orally, or to decompress the GI tract in obstruction and post-operative ileus.

KNT devices are Class II medical devices, regulated under 21 CFR 876.5980 and reviewed by the FDA Gastroenterology & Urology panel.

Leading manufacturers include Biosearch Medical Products, Inc., Abbott Laboratories and C.R. Bard, Inc..

650
Total
650
Cleared
153d
Avg days
1976
Since
Declining activity - 7 submissions in the last 2 years vs 14 in the prior period
Consistent review times: 162d avg (recent)

FDA 510(k) Cleared Tubes, Gastrointestinal (and Accessories) Devices (Product Code KNT)

650 devices
1–24 of 650
Cleared Jul 10, 2026
Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220)
K253514
C.R. Bard, Inc.
Gastroenterology & Urology · 246d
Cleared Apr 10, 2025
XNY Disposable Gastric Calibration Tube
K250389
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Gastroenterology & Urology · 58d
Cleared Mar 28, 2025
Flexi-Seal AIR (with ENFit Connector)
K243228
Convatec
Gastroenterology & Urology · 171d
Cleared Jan 17, 2025
hygh-tec Drainage II
K242336
Amb Medtec
Gastroenterology & Urology · 163d
Cleared Jan 10, 2025
ZZIREN™ Orogastric Tube
K242901
Tools For Surgery, LLC
Gastroenterology & Urology · 109d
Cleared Nov 22, 2024
Entarik NI Feeding Tube System
K241169
Gravitas Medical, Inc.
Gastroenterology & Urology · 210d
Cleared Oct 25, 2024
CORGRIP* SR NG/NI Tube Retention System
K241185
Avanos Medical, Inc.
Gastroenterology & Urology · 179d
Cleared Jun 06, 2024
CORTRAK* 2 Enteral Access System (20-0950)
K240965
Avanos Medical, Inc.
Gastroenterology & Urology · 58d
Cleared May 31, 2024
Stylus
K233591
Degania Silicone , Ltd.
Gastroenterology & Urology · 205d
Cleared May 16, 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039
Reshape Lifesciences
Gastroenterology & Urology · 30d
Cleared May 06, 2024
ViSiGi LUX (5332)
K234033
Boehringer Laboratories, LLC
Gastroenterology & Urology · 138d
Cleared Apr 17, 2024
Enteral Feeding Sets
K240039
Hangzhou Primecare Medical Co., Ltd.
Gastroenterology & Urology · 103d
Cleared Feb 08, 2024
Endolumik Gastric Calibration Tube M Series (EGCT36M)
K240069
Endolumik
Gastroenterology & Urology · 30d
Cleared Jan 26, 2024
ViSiGi 3D Gastric Sizing Tube
K234145
Boehringer Laboratories
Gastroenterology & Urology · 28d
Cleared Dec 18, 2023
AMT G-Tube Balloon Gastrostomy Feeding Device
K222846
Applied Medical Technology, Inc.
Gastroenterology & Urology · 453d
Cleared Mar 24, 2023
Entarik Feeding Tube System
K230206
Gravitas Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Mar 03, 2023
Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)
K222880
Endolumik, Inc.
Gastroenterology & Urology · 162d
Cleared Feb 15, 2023
ReShape Calibration Tubes
K230131
Reshape Lifesciences
Gastroenterology & Urology · 29d
Cleared Feb 09, 2023
hygh-tec drainage
K221400
Creative Balloons GmbH
Gastroenterology & Urology · 269d
Cleared Oct 31, 2022
Standard Tapered Bougie, 38 Fr.
K222085
Standard Bariatrics, Inc.
Gastroenterology & Urology · 108d
Cleared Sep 30, 2022
DoubleChek DC-1001
K212316
Nasogastric Feeding Solutions, Ltd.
Gastroenterology & Urology · 431d
Cleared Jul 28, 2022
Gastrointestinal Boundary Identifier (GIBI HD)
K221898
Reshape Lifesciences
Gastroenterology & Urology · 28d
Cleared Jul 26, 2022
Gastric Lightguide (GLG)
K212407
Naser Dib Gabinet Lekarksi Nasmed
Gastroenterology & Urology · 357d
Cleared Jun 07, 2022
Lap-Band System Calibration Tube
K220455
Reshape Lifesciences
Gastroenterology & Urology · 110d

About Product Code KNT - Regulatory Context

510(k) Submission Activity

650 total 510(k) submissions under product code KNT since 1976, with 650 receiving FDA clearance (average review time: 153 days).

Submission volume has declined in recent years - 7 submissions in the last 24 months compared to 14 in the prior period.

FDA 510(k) Review Time - KNT Product Code

FDA review times for KNT submissions have been consistent, averaging 162 days recently vs 152 days historically.

KNT devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →