2008K@HOME HEMODIALYSIS MACHINE
FDA 510(k) clearance K124035 · decided 2013-07-03
Clearance details
- K-number
- K124035
- Device name
- 2008K@HOME HEMODIALYSIS MACHINE
- Applicant
- Fresenius Medical Care North America
- Decision
- Substantially Equivalent
- Date received
- 2012-12-28
- Decision date
- 2013-07-03
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- ONW
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) (K242269) | Quanta Dialysis Technologies, Ltd. | 2024-11-01 |
| FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) (K121421) | Fresenius Medical Care North America, Design Cente | 2013-01-17 |
| FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (K070049) | Fresenius Medical Care North America | 2011-02-03 |
Recalls involving this device
No recalls on record reference this clearance.