CDS 2001 Artificial Kidney
by Elmar Medical Systems, Ltd.
510(k) K831376
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831376 | Date3 Jun 1983 | 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- Withdrawn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
- KOC
- 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 CDS 2001 Artificial Kidney is a hemodialysis device designed as an artificial kidney system for patients with renal failure or toxemic conditions. It functions by filtering blood through an extracorporeal blood circuit, dialyzer, and dialysate delivery system to remove waste and excess fluids, mimicking the natural function of healthy kidneys.
This device is supplied as a reusable medical system, intended for use in clinical settings such as hospitals or dialysis centers. It operates under sterile conditions and requires proper maintenance and cleaning between uses. The CDS 2001 is classified under FDA regulation number 876.5820 and holds a 510(k) clearance (K831376) for traditional review, with a product code of KOC. It is intended for use in urology and gastroenterology specialties.
Questions
AI-generated answers, 1 Oct 2026
What is the CDS 2001 Artificial Kidney used for?
The CDS 2001 Artificial Kidney is designed to function as an artificial kidney system for patients suffering from renal failure or toxemic conditions. It works by filtering blood through an extracorporeal circuit, dialyzer, and dialysate delivery system to remove waste products and excess fluids, effectively replicating the natural function of healthy kidneys. This device is intended for use in clinical environments like hospitals or dialysis centers.
Is the CDS 2001 Artificial Kidney reusable or single-use?
The CDS 2001 Artificial Kidney is supplied as a reusable medical system. It is intended for repeated use in clinical settings, provided it undergoes proper maintenance, cleaning, and sterilization between uses to ensure safety and efficacy.
What specialties is the CDS 2001 Artificial Kidney approved for?
The CDS 2001 Artificial Kidney is classified under FDA regulation number 876.5820 and is intended for use in the specialties of urology and gastroenterology. This approval reflects its role in managing conditions related to renal failure and toxin removal, which are relevant to both specialties.
How is the CDS 2001 Artificial Kidney supplied and maintained?
The CDS 2001 is supplied as a reusable system for clinical use, meaning it is designed to be used multiple times with appropriate care. Between uses, it must be thoroughly cleaned and maintained to prevent contamination and ensure proper function. Sterility is maintained through proper cleaning protocols and sterilization procedures as outlined by the manufacturer.
What regulatory pathway does the CDS 2001 Artificial Kidney follow?
The CDS 2001 Artificial Kidney holds a 510(k) clearance (K831376) through the traditional review pathway, as indicated by its FDA authorization. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets the necessary regulatory standards for safety and effectiveness.