Top Disposable Infusion Set
by Top Surgical Manufacturers Co.
510(k) K841025
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841025 | Date30 Mar 1984 | 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- Withdrawn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
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Top Disposable Infusion Set is a single-use medical device classified as an infusion pump accessory under the FDA’s product code FPA. It is designed to deliver intravenous fluids, medications, or nutrients directly into a patient’s bloodstream via a sterile, disposable pathway, ensuring reliable fluid administration in hospital settings. Constructed for one-time use, the set includes a spike, tubing, and a connector to interface with infusion pumps or bags. Its primary function is to maintain a secure, leak-free connection during fluid therapy, reducing the risk of contamination or infusion errors.
This infusion set is supplied sterile and intended for single-use in clinical environments such as general hospitals. It is manufactured by Top Surgical Manufacturers Co. and holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of March 30, 1984. The device is not labeled for MRI compatibility or reusable applications. Storage instructions and additional regulatory details are not specified in the available data, but compliance with standard sterile packaging and handling protocols is implied for safe use.
Other devices from Top Surgical Manufacturers Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Top Disposable Infusion Set designed for?
The Top Disposable Infusion Set is specifically designed to deliver intravenous fluids, medications, or nutrients directly into a patient’s bloodstream. It serves as an accessory for infusion pumps or bags, ensuring a secure, leak-free connection during fluid therapy in clinical settings like general hospitals. Its primary purpose is to minimize the risk of contamination or infusion errors by providing a sterile, disposable pathway.
How is the Top Disposable Infusion Set supplied and intended for use?
The infusion set is supplied sterile and is intended exclusively for single-use applications. This design eliminates the need for reprocessing and reduces the risk of cross-contamination between patients. It is manufactured for use in hospital environments where reliable, one-time fluid administration is critical.
Does this infusion set support reusable applications or MRI compatibility?
No, the Top Disposable Infusion Set is explicitly labeled for single-use only and is not designed for reuse. Additionally, it is not labeled for MRI compatibility, meaning it should not be used in MRI environments unless explicitly stated otherwise by the manufacturer in updated documentation.
What components does the Top Disposable Infusion Set include?
The set includes a spike for connecting to fluid bags, tubing to channel the fluids, and a connector to interface with infusion pumps. These components work together to create a sterile pathway for fluid administration, ensuring a secure and leak-free connection during use.
What regulatory clearance does the Top Disposable Infusion Set hold?
The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of March 30, 1984. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device under the FDA’s product code FPA for infusion pump accessories.