Transfer Needle
510(k) K854556
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854556 | Date16 Jan 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- Withdrawn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
- LHI
- 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 Transfer Needle is a medical device classified under the FDA product code LHI, designed for transferring fluids between containers or systems in a clinical setting. It is a sterile, single-use instrument intended to facilitate precise fluid transfer while maintaining aseptic conditions. This device is commonly used in hospital environments to connect intravenous lines, syringes, or other fluid pathways without direct contamination.
Supplied as a sterile, single-use item, the Transfer Needle is intended for use in general hospital settings. It adheres to FDA 510(k) clearance (K854556) under a Traditional review pathway, with a decision of Substantially Equivalent to the predicate device. No additional regulatory markings or MRI safety classifications are specified. Storage should follow standard sterile medical device protocols to ensure integrity prior to use.
Questions
AI-generated answers, 1 Oct 2026
What is the Transfer Needle designed for in clinical settings?
The Transfer Needle is specifically engineered to transfer fluids between containers or systems while preserving aseptic conditions. This makes it ideal for connecting intravenous lines, syringes, or other fluid pathways in hospital environments without risking contamination. Its design ensures minimal disruption to the fluid pathway, reducing the chance of leaks or spills during transfers.
Is the Transfer Needle reusable or intended for single-use?
The Transfer Needle is explicitly intended for single-use only. This design choice aligns with best practices for maintaining sterility and infection control in clinical settings. Single-use devices like this one are discarded after one use to prevent cross-contamination between patients or procedures.
How should the Transfer Needle be stored before use?
The Transfer Needle must be stored following standard sterile medical device protocols to ensure its integrity before use. This typically involves keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage prevents damage to the sterile barrier and maintains the device’s functionality for its intended single-use application.
What regulatory pathway does the Transfer Needle follow?
The Transfer Needle has undergone FDA 510(k) clearance under the Traditional review pathway, with a decision of Substantially Equivalent to its predicate device. This means it has been evaluated by the FDA to demonstrate that it performs similarly to a previously approved device without introducing new risks. The clearance number for this device is K854556.
Can the Transfer Needle be used with any fluid type in a hospital?
The Transfer Needle is designed for general fluid transfer applications in hospital settings, such as connecting intravenous lines or syringes. While it is versatile for common clinical fluids, it is not explicitly indicated for use with all fluid types—such as hazardous or non-sterile substances. Always verify compatibility with the specific fluids being transferred and adhere to facility protocols for safe handling.