Lake N/G Extension Set
by Lake Medical Products, Inc.
510(k) K884128
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884128 | Date8 Dec 1988 | 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- Withdrawn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, 19 Sep 2026
The Lake N/G Extension Set is a medical device classified as an Intravenous Extension Set (Product Code: KNT). It is designed to connect intravenous fluids or medications to a primary infusion line, facilitating continuous administration while maintaining sterility and flow integrity. Constructed for compatibility with nasogastric (N/G) feeding tubes, it ensures safe and efficient delivery of nutrients or medications directly into the gastrointestinal tract.
This extension set is supplied as a single-use, sterile device, intended for use in clinical settings such as hospitals or outpatient care. It is regulated under FDA 510(k) clearance (K884128) and falls under the Gastroenterology and Urology advisory committee classifications. No additional regulatory status beyond the stated FDA clearance is implied. Proper storage requires protection from contamination and adherence to manufacturer guidelines to maintain sterility.
Other devices from Lake Medical Products, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the Lake N/G Extension Set primarily used for in clinical settings?
The Lake N/G Extension Set is designed to connect intravenous fluids or medications to a primary infusion line, specifically for safe and efficient delivery through nasogastric (N/G) feeding tubes. This allows continuous administration of nutrients or medications directly into the gastrointestinal tract while maintaining sterility and flow integrity.
Is the Lake N/G Extension Set intended for single-use or can it be reused?
The Lake N/G Extension Set is explicitly supplied as a single-use, sterile device. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and compromise patient safety.
How should the Lake N/G Extension Set be stored to maintain its sterility?
The device must be stored in a way that protects it from contamination. The manufacturer’s guidelines should be followed to ensure sterility is preserved, as improper storage could compromise its intended use and safety.
What regulatory pathway does the Lake N/G Extension Set follow, and how was its clearance determined?
The Lake N/G Extension Set follows the FDA’s 510(k) clearance pathway, specifically under the classification of Intravenous Extension Sets (Product Code: KNT). Its clearance was determined through a traditional review process, with the FDA concluding it is *substantially equivalent* to a legally marketed predicate device.
Are there different sizes or models available for the Lake N/G Extension Set?
The provided specifications do not detail specific sizes or models for the Lake N/G Extension Set. However, it is designed for compatibility with nasogastric feeding tubes, so compatibility would depend on the tube’s dimensions. For exact sizing options, refer to the manufacturer’s product documentation or contact Lake Medical Products directly.