AMSINO I.V. Administration Set
510(k) K973107
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973107 | Date2 Oct 1997 | 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- Withdrawn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, 19 Sep 2026
The AMSINO I.V. Administration Set is a gravity-fed intravenous administration device designed for the controlled delivery of fluids, medications, or nutrients directly into a patient’s venous system. It features a pre-pierced Y-site, allowing for secondary infusions without additional needle insertion, and is classified as a nonvented IV administration set under regulatory nomenclature.
This set is supplied sterile, intended for single-use only, and includes a roller clamp, Sure-Lok needle-free Y-site, and a rotating male Luer lock connector. The tubing measures approximately 83 inches (211 cm) in length with a drop factor of 15 drops per milliliter and a priming volume of about 16 mL. Authorized for use in general hospital settings, it adheres to FDA 510(k) clearance under the product code FPA, with no third-party certification indicated.