FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
FDA 510(k) clearance K121421 · decided 2013-01-17
Clearance details
- K-number
- K121421
- Device name
- FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)
- Applicant
- Fresenius Medical Care North America, Design Cente
- Decision
- Substantially Equivalent
- Date received
- 2012-05-14
- Decision date
- 2013-01-17
- Days to decision
- 248 days
- Clearance type
- Special
- 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 |
| 2008K@HOME HEMODIALYSIS MACHINE (K124035) | Fresenius Medical Care North America | 2013-07-03 |
| FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (K070049) | Fresenius Medical Care North America | 2011-02-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190 recall (Z-1549-2015) | Fresenius Medical Care Holdings, Inc. | 2015-04-29 |
| ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T He recall (Z-1015-2015) | Fresenius Medical Care Holdings, Inc. | 2015-01-27 |