Bio-Carb D16000, D16001, and D17000
by Societe D' Analyses Bio-Pharmaceutiques, Inc.
510(k) K861646
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK861646 | Date7 Aug 1986 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- FJH
- FDA applicant
- Societe D' Analyses Bio-Pharmaceutiques,Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5830
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bio-Carb D16000, D16001, and D17000 are disposable dialyzers classified under FDA regulation 876.5830, designed for use in hemodialysis procedures. These devices are intended for renal dialysis applications, facilitating the removal of waste products and excess fluids from the bloodstream through a semipermeable membrane. They fall under the medical specialty categories of gastroenterology and urology, though their primary function is within renal therapy.
Supplied as single-use devices, the Bio-Carb dialyzers are intended for sterile use in controlled clinical settings such as dialysis centers. Each model (D16000, D16001, D17000) is distinct by its specifications, though all adhere to FDA clearance under 510(k) number K861646 with a traditional review process. The devices are regulated as Class II medical devices and must be handled according to manufacturer guidelines to ensure proper functionality and patient safety.
Questions
AI-generated answers, 1 Oct 2026
What is the Bio-Carb D16000, D16001, and D17000 used for?
These devices are disposable dialyzers designed specifically for hemodialysis procedures. They facilitate the removal of waste products and excess fluids from the bloodstream through a semipermeable membrane, ensuring renal function support for patients undergoing dialysis. Each model (D16000, D16001, D17000) is tailored for this purpose, adhering to FDA-cleared standards for safety and efficacy.
Are the Bio-Carb dialyzers single-use or reusable?
The Bio-Carb dialyzers (D16000, D16001, D17000) are explicitly designed as single-use devices. This ensures sterility and reduces the risk of contamination or cross-infection in clinical settings, aligning with best practices for hemodialysis safety. Reuse is not recommended or supported by the manufacturer.
What distinguishes the D16000, D16001, and D17000 models?
While the exact specifications for each model are not detailed in the provided data, the Bio-Carb dialyzers are categorized under FDA regulation 876.5830 and cleared under 510(k) number K861646. The differences between the models (D16000, D16001, D17000) are likely based on technical specifications such as membrane surface area, blood flow rate, or dialysate flow rate, which are tailored for specific patient needs or dialysis protocols. Always refer to the manufacturer’s documentation for precise model comparisons.
How should the Bio-Carb dialyzers be stored?
The Bio-Carb dialyzers must be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Since they are sterile single-use devices, they should remain in their original packaging until immediately before use. Proper storage ensures the integrity of the device and maintains its sterility, which is critical for safe hemodialysis procedures.
What regulatory pathway does the Bio-Carb dialyzer follow?
The Bio-Carb dialyzers (D16000, D16001, D17000) are classified as Class II medical devices under FDA regulation 876.5830 and have undergone a traditional 510(k) review process. This pathway ensures that the devices meet established safety and performance standards before entering the market. The FDA clearance number for this product is K861646, confirming compliance with regulatory requirements.