5UM Filterset with Y-Injection Site
by Abbott Laboratories 510(k)
Active
510(k) K771972
Overview
This device is a Filter, Infusion Line (FDA classification: Class II) designed to remove particulate matter from intravenous infusion fluids. The 5 µm filterset incorporates a Y-injection site, enabling simultaneous infusion and medication administration while maintaining sterility and fluid integrity during administration.
The filterset is supplied as a single-use, non-sterile device intended for use in general hospital settings. It is regulated under FDA 510(k) clearance (K771972) and adheres to regulation number 880.5440. The product code is FPB, and it is manufactured by Abbott Laboratories. Storage and handling follow standard aseptic practices for infusion components, with no MRI safety considerations specified.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771972 | Date3 Jan 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FPB
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the primary purpose of the 5 µm Filterset with Y-Injection Site, and how does the Y-injection site enhance its functionality?
The 5 µm Filterset with Y-Injection Site is designed to remove particulate matter from intravenous infusion fluids, ensuring cleaner administration to patients. The Y-injection site allows simultaneous infusion of fluids *and* medication administration without disrupting the filter’s sterility or fluid integrity, making it ideal for scenarios where multiple treatments or additives are needed during a single infusion.
Is this device intended for reuse, or is it meant to be used only once? How should it be handled to maintain safety?
This device is explicitly labeled as single-use only. Since it is non-sterile as supplied, proper aseptic handling and storage practices are required before use, following standard protocols for infusion components to prevent contamination. Reuse is not recommended or supported by the manufacturer.
What storage conditions should be followed for the 5 µm Filterset with Y-Injection Site, and are there any special considerations for its use?
The device must be stored according to standard aseptic practices for infusion components, as no specific storage conditions (e.g., temperature, humidity) are detailed in the data. There are no MRI safety considerations mentioned, so it can be used in MRI environments without restrictions. Always ensure the packaging remains intact until immediate use.
How do I verify the regulatory compliance of this device before purchasing or using it?
This device holds FDA 510(k) clearance (K771972) under regulation number 880.5440, with a product code of FPB. The clearance was granted in 1978 and is classified as substantially equivalent (SESE) to predicate devices. For full compliance verification, check the FDA’s OpenFDA database using the registration numbers or product code listed in the data.