Y2K2 Enternal Feeding Manager
510(k) K030413
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030413 | Date11 May 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Y2K2 Enteral Feeding Manager is a gastrointestinal tube and accessory designed to provide enteral feeding. It functions to accurately deliver small volumes of nutrition enterally to pediatric, adult, or elderly patients who are unable to consume an adequate diet orally.
This device is identified under FDA 510(k) clearance number K030413. It is manufactured by Moss Medical Products and is categorized under the gastroenterology and urology advisory committee.
Other devices from Moss Medical Products
Questions
AI-generated answers, 27 Sep 2026
What is the primary function of the Y2K2 Enteral Feeding Manager?
The Y2K2 Enteral Feeding Manager is a gastrointestinal tube and accessory designed to provide enteral nutrition. It is specifically engineered to deliver small, accurate volumes of nutrition to pediatric, adult, or elderly patients who are unable to consume an adequate diet through oral intake.
What is the regulatory status of this device?
The Y2K2 Enteral Feeding Manager is identified under FDA 510(k) clearance number K030413. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the gastroenterology and urology product categories.
Who is the manufacturer of the Y2K2 Enteral Feeding Manager?
This device is manufactured by Moss Medical Products, located in White Plains, New York. The company is the official applicant for the device's 510(k) clearance, which was processed under the gastroenterology and urology advisory committee.