Aseptic Fluid Transfer System
510(k) K830811
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830811 | Date28 Apr 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KQQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Aseptic Fluid Transfer System is a sterile medical device classified as Tubing, Dialysate (and Connector) under FDA product code KQQ. It is designed for maintaining aseptic conditions during the transfer of fluids, ensuring contamination-free connections in medical applications such as hemodialysis or other fluid therapy procedures. This system is intended for use in clinical settings where sterile fluid pathways are critical to patient safety.
Supplied as a single-use device, the Aseptic Fluid Transfer System is intended for sterile use in controlled environments such as dialysis centers or urology/gastroenterology procedures. It is regulated under FDA 510(k) clearance (K830811) and falls under Class II medical devices, adhering to FDA regulation number 876.5820. The system is not MRI-compatible and must be stored in its original packaging until use to preserve sterility.
Questions
AI-generated answers, 1 Oct 2026
What is the Aseptic Fluid Transfer System designed for?
The Aseptic Fluid Transfer System is specifically engineered to maintain aseptic conditions during the transfer of fluids in medical procedures. It is particularly suited for hemodialysis and other fluid therapy applications where sterile pathways are critical to patient safety, such as in dialysis centers or urology/gastroenterology procedures. Its design ensures contamination-free connections, reducing the risk of infection or complications during treatment.
Is the Aseptic Fluid Transfer System intended for single-use or reuse?
This system is supplied as a single-use device. It is designed for sterile use in controlled clinical environments, and reuse is not recommended or intended. Using it more than once could compromise sterility and patient safety, so it must be discarded after a single use.
How should the Aseptic Fluid Transfer System be stored to maintain sterility?
To preserve sterility, the Aseptic Fluid Transfer System must be stored in its original packaging until the time of use. Opening or removing it from its packaging prior to use could expose it to contaminants, violating its sterile field. Always check the packaging for signs of damage or tampering before use.
Can the Aseptic Fluid Transfer System be used in MRI environments?
No, the Aseptic Fluid Transfer System is explicitly noted as not MRI-compatible. This means it should not be used in magnetic resonance imaging environments, as exposure to MRI fields could potentially affect its performance or integrity. Always verify compatibility with the specific clinical setting before use.
What regulatory approval does the Aseptic Fluid Transfer System hold?
The Aseptic Fluid Transfer System holds FDA 510(k) clearance under the reference number K830811. It is classified as a Class II medical device and adheres to FDA regulation number 876.5820. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets applicable safety and performance standards.