ONW — Hemodialysis System For Home Use Class II
FDA product code ONW covers "Hemodialysis System For Home Use", a Class II medical device regulated under 21 CFR 876.5860. Submissions are reviewed by the Gastroenterology, Urology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ONW
- Device Class
- Class II
- Regulation Number
- 876.5860
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242269 | quanta dialysis technologies | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube S | November 1, 2024 |
| K124035 | fresenius medical care north america | 2008K@HOME HEMODIALYSIS MACHINE | July 3, 2013 |
| K121421 | fresenius medical care north america, design cente | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALE | January 17, 2013 |
| K070049 | fresenius medical care north america | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | February 3, 2011 |