Powdered Bicarbonate Concentrate
510(k) K865078
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK865078 | Date27 Mar 1987 | 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- Withdrawn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
- KPO
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Powdered Bicarbonate Concentrate is a Dialysate Concentrate for Hemodialysis (Liquid or Powder) as classified under FDA regulation 876.5820. This medical device provides a concentrated form of bicarbonate, a key electrolyte used to balance acidity in the blood during hemodialysis procedures, ensuring proper metabolic function for patients undergoing renal replacement therapy.
Supplied as a powder, this concentrate is intended for use in hemodialysis machines to prepare dialysate solutions. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance (K865078) as substantially equivalent to a predicate device. The product is regulated for medical specialties in Gastroenterology and Urology, though its primary application remains within hemodialysis settings. No sterility or single-use/reusable designation is specified in the data.
Other devices from Bicarbolyte Corp.
Questions
AI-generated answers, 19 Sep 2026
What is the Powdered Bicarbonate Concentrate used for in clinical settings?
The Powdered Bicarbonate Concentrate is designed specifically for hemodialysis procedures. It serves as a concentrated source of bicarbonate, an essential electrolyte that helps balance acidity in a patient’s blood during dialysis. This ensures proper metabolic function for individuals undergoing renal replacement therapy, particularly those with end-stage kidney disease.
How is the Powdered Bicarbonate Concentrate supplied, and what form does it take?
The concentrate is supplied exclusively as a powder. It is intended to be mixed with water or another compatible solution to prepare dialysate for use in hemodialysis machines. The powder form allows for easy storage, handling, and precise dosing in clinical settings.
Is the Powdered Bicarbonate Concentrate intended for single-use or can it be reused?
The provided data does not specify whether the Powdered Bicarbonate Concentrate is designated for single-use or reuse. Clinicians should follow manufacturer guidelines and facility protocols to ensure proper use, safety, and compliance with regulatory standards.
What regulatory pathway was followed for FDA clearance of this product?
The Powdered Bicarbonate Concentrate received FDA 510(k) clearance under the traditional review pathway, with the clearance number K865078. It was determined to be *substantially equivalent* to a predicate device, meaning it was evaluated against an already approved product to demonstrate safety and effectiveness. The product is classified as a Class II device under FDA regulations.
Are there any special storage requirements for the Powdered Bicarbonate Concentrate?
While the data does not specify exact storage conditions, powdered medical concentrates like this typically require protection from moisture, contamination, and extreme temperatures. Facilities should store it in a dry, sealed environment as recommended by the manufacturer to maintain potency and sterility (if applicable) until use.