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 Avanos Medical, Inc., Applied Medical Technology, Inc. and Degania Silicone , Ltd..
FDA 510(k) Cleared Tubes, Gastrointestinal (and Accessories) Devices (Product Code KNT)
About Product Code KNT - Regulatory Context
510(k) Submission Activity
649 total 510(k) submissions under product code KNT since 1976, with 649 receiving FDA clearance (average review time: 152 days).
Submission volume has declined in recent years - 9 submissions in the last 24 months compared to 15 in the prior period.
FDA Review Time
FDA review times for KNT submissions have been consistent, averaging 131 days recently vs 153 days historically.
KNT devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →