Haemodialysis Concentrate (KPO)
by Bdh, Inc.
510(k) K904946
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904946 | Date9 Apr 1991 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Haemodialysis Concentrate
- 510(k) Number
- FDA Product Code
- KPO
- 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 Haemodialysis Concentrate (KPO) is a Dialysate Concentrate for Hemodialysis (liquid or powder), designed to prepare dialysate solutions for haemodialysis procedures. It provides essential electrolytes and minerals required to maintain fluid and electrolyte balance in patients undergoing renal replacement therapy. This concentrate is formulated to be mixed with water to create the final dialysate solution used in haemodialysis machines.
Supplied as a sterile, single-use product, the Haemodialysis Concentrate (KPO) is intended for use in clinical settings such as dialysis centres and hospitals. It adheres to regulatory standards under FDA 510(k) clearance (K904946) and Regulation 876.5820, ensuring compliance with haemodialysis device requirements. The concentrate is available in specified formulations for liquid or powder applications, with storage conditions typically requiring protection from moisture and contamination. No MRI safety considerations apply, as it is not a magnetic resonance-compatible device.
Questions
AI-generated answers, 1 Oct 2026
What is the Haemodialysis Concentrate (KPO) used for?
The Haemodialysis Concentrate (KPO) is designed to prepare dialysate solutions used in haemodialysis procedures. It supplies essential electrolytes and minerals to maintain fluid and electrolyte balance in patients undergoing renal replacement therapy. This concentrate is specifically formulated to be mixed with water to create the final dialysate solution required by haemodialysis machines.
How is the Haemodialysis Concentrate (KPO) supplied and what are its storage requirements?
The Haemodialysis Concentrate (KPO) is supplied as a sterile, single-use product. To maintain its integrity, it must be stored in a way that protects it from moisture and contamination. Proper storage ensures the concentrate remains effective and safe for clinical use in dialysis centres or hospitals.
Is the Haemodialysis Concentrate (KPO) reusable or intended for single-use?
The Haemodialysis Concentrate (KPO) is explicitly designed for single-use only. This ensures patient safety and sterility, as reuse could compromise the concentrate’s integrity and introduce contamination risks during haemodialysis procedures.
What regulatory approvals does the Haemodialysis Concentrate (KPO) hold?
The Haemodialysis Concentrate (KPO) holds FDA 510(k) clearance under the reference number K904946, adhering to regulatory standards outlined in FDA Regulation 876.5820. This clearance confirms its compliance with haemodialysis device requirements as determined by the regulatory body.
Are there any special considerations for handling or compatibility with other devices?
The Haemodialysis Concentrate (KPO) does not require any special MRI safety considerations, as it is not a magnetic resonance-compatible device. It is intended for use exclusively in haemodialysis machines and should be handled in clinical settings following standard sterile procedures to ensure safe and effective use.