5 in 1 Connector
510(k) K861757
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861757 | Date6 Jun 1986 | 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- Withdrawn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
- GAZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The 5 in 1 Connector is a medical-grade connector designed to facilitate the simultaneous connection of five distinct fluid pathways in a single device. It is classified under product code GAZ, intended for use in hospital settings to streamline intravenous, infusion, or other fluid administration systems by consolidating multiple inputs into one compact interface.
This connector is supplied as a reusable device and is intended for use in general hospital environments. It has received FDA 510(k) clearance under K861757, with a decision date of June 6, 1986, and is regulated under the Traditional clearance type. No specific sterility or MRI safety information is provided in the available data, though it is designed for clinical use where multiple fluid lines must be managed efficiently.
Questions
AI-generated answers, 1 Oct 2026
What is the 5-in-1 Connector designed for?
The 5-in-1 Connector is engineered to streamline fluid administration in hospital settings by allowing simultaneous connection of five distinct fluid pathways into a single interface. This design reduces complexity and potential errors when managing multiple intravenous or infusion lines, making it particularly useful in general hospital environments where efficient fluid management is critical.
Is the 5-in-1 Connector reusable or single-use?
The 5-in-1 Connector is supplied as a reusable device. This classification aligns with its intended use in clinical settings where durability and repeated use are necessary to maintain workflow efficiency, particularly in environments like hospitals where multiple patients may require fluid administration.
What regulatory clearance does the 5-in-1 Connector hold?
The 5-in-1 Connector has received FDA 510(k) clearance under the reference number K861757, with a decision date of June 6, 1986. It was classified as substantially equivalent to a predicate device and is regulated under the Traditional clearance type, with an advisory committee designation of General Hospital (HO).
Are there any specific sterility or MRI safety details provided for this connector?
The available data for the 5-in-1 Connector does not include explicit information regarding sterility or MRI safety. While it is designed for clinical use in environments where multiple fluid lines must be managed efficiently, users should consult additional manufacturer guidelines or clinical protocols to ensure proper handling and compatibility with MRI equipment if needed.
How is the 5-in-1 Connector categorized in terms of product classification?
The 5-in-1 Connector falls under FDA product code GAZ, which categorizes it as a device intended for general hospital use. This classification reflects its role in facilitating fluid administration systems, ensuring it meets regulatory standards for hospital environments.