Low-Acetate Hemodialysis Bath Concentrate
by Travenol Laboratories, S.A. 510(k)
Active
510(k) K800624
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800624 | Date14 Jul 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- Full name
- Low-Acetate Hemodialysis Bath Concentr.
- 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
This device is a Dialysate Concentrate for Hemodialysis (Liquid or Powder), designed to prepare hemodialysis bath solutions with reduced acetate content. It is intended for use in renal replacement therapy to facilitate the removal of waste products and excess fluids from the blood of patients with acute or chronic kidney disease. The formulation supports electrolyte balance while minimizing metabolic acidosis risks associated with higher acetate levels.
The concentrate is supplied as a sterile, single-use liquid for preparation in dialysis centers and hospitals. It is regulated under FDA 510(k) clearance (K800624) and classified as a Class II medical device under regulation 876.5820. Compliance with hemodialysis standards ensures compatibility with existing dialysis machines and protocols. Storage and handling follow standard aseptic practices for sterile concentrates, with no MRI safety considerations due to its non-magnetic composition.
Other devices from Travenol Laboratories, S.A.
Questions
AI-generated answers, 1 Oct 2026
What is the low-acetate hemodialysis bath concentrate used for?
This concentrate is designed for preparing hemodialysis bath solutions with reduced acetate levels. It supports renal replacement therapy by aiding the removal of waste products and excess fluids from the blood of patients with acute or chronic kidney disease. The reduced acetate formulation helps minimize the risk of metabolic acidosis, which can occur with higher acetate levels in traditional dialysis solutions.
How is the low-acetate hemodialysis bath concentrate supplied?
The concentrate is supplied as a sterile, single-use liquid. It is intended for use in dialysis centers and hospitals, where it can be prepared according to standard protocols. The sterile packaging ensures safety and compatibility with existing dialysis machines.
Is the low-acetate hemodialysis bath concentrate reusable or single-use?
This concentrate is explicitly designed for single-use only. Using it more than once could compromise sterility and patient safety, as it is intended to be prepared fresh for each dialysis session. Always follow the manufacturer’s guidelines for proper disposal after use.
What storage and handling precautions should be taken for this concentrate?
The concentrate must be stored and handled under standard aseptic practices for sterile medical devices. This includes maintaining a clean, dry environment, protecting it from contamination, and adhering to temperature guidelines if applicable. Since it is non-magnetic, there are no special MRI safety considerations, but always follow the manufacturer’s instructions for optimal storage.
Is this device compatible with all dialysis machines?
Yes, the low-acetate hemodialysis bath concentrate is designed to comply with hemodialysis standards, ensuring compatibility with most standard dialysis machines and protocols in use today. However, it is always recommended to verify compatibility with your specific equipment before use, as minor variations in machine specifications may exist.