Enteral Feeding Sets
by Hangzhou Primecare Medical Co., Ltd. 510(k)
Active
510(k) K240039
Overview
The Enteral Feeding Sets are classified as gastrointestinal tube and accessories, designed for the administration of liquid nutrition directly into the gastrointestinal tract when enteral feeding pumps are unavailable. These sets provide a controlled pathway for nutrient delivery, ensuring safe and efficient feeding in clinical or home settings. The rigid neck facilitates filling and handling, while the soft cap allows for easy opening and closing of the tubing.
These sets are supplied as single-use devices, intended for one-time use to prevent contamination. They are available in various tubing bores to accommodate different patient needs. The device is regulated under FDA 510(k) clearance (K240039) and falls under the Gastrointestinal tube and accessories classification (Product Code: KNT). No additional sterility or MRI safety information is specified in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240039 | Date17 Apr 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 26 Oct 2026.
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
Other devices from Hangzhou Primecare Medical Co., Ltd.
Questions
What are Primecare Enteral Feeding Sets designed for?
Primecare Enteral Feeding Sets are designed for the administration of liquid nutrition directly into the gastrointestinal tract when enteral feeding pumps are unavailable. They provide a controlled pathway for safe and efficient feeding in both clinical and home settings. The rigid neck of the tubing simplifies filling and handling, while the soft cap ensures easy opening and closing without compromising sterility.
Are these feeding sets single-use or reusable?
These Enteral Feeding Sets are intended for single-use only to prevent contamination and ensure patient safety. Each set is packaged sterile and should not be reused after a single administration, even if portions remain unused. Reuse increases the risk of bacterial growth and cross-contamination, which could lead to infections or feeding complications.
What tubing sizes are available for Primecare Enteral Feeding Sets?
The Enteral Feeding Sets come in various tubing bores to accommodate different patient needs, though the exact sizes are not specified in the provided data. The choice of tubing size typically depends on factors like patient age, tube type (e.g., nasogastric or gastrostomy), and recommended flow rates for safe and effective enteral feeding. Always verify compatibility with the patient’s feeding tube and clinical guidelines.
How should these feeding sets be stored before use?
Since these sets are single-use and sterile, they should be stored in their original, sealed packaging in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Avoid storing them in areas with high humidity or chemical exposure, as this could compromise sterility. Check the packaging for expiration dates and ensure the seal remains intact before use.
What regulatory pathway does Primecare’s Enteral Feeding Sets follow?
Primecare’s Enteral Feeding Sets are regulated under the FDA 510(k) clearance process, specifically classified under Product Code KNT (Gastrointestinal tube and accessories). The device was determined to be substantially equivalent to a legally marketed predicate and received clearance (K240039) on April 17, 2024, after review by the Gastroenterology and Urology (GU) Advisory Committee. This classification ensures compliance with U.S. medical device regulations for enteral feeding accessories.