Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)
FDA 510(k) K121421 · Fresenius Medical Care North America, Design Cente
510(k) numberK121421
Submission
- Device name
- Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert)
- Applicant
- Fresenius Medical Care North America, Design Cente
Waltham, MA, US - Received
- May 14, 2012
- Decision date
- January 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONW – Hemodialysis System For Home Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Other 510(k)s with product code ONW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set…ONW · Traditional | Quanta Dialysis Technologies, Ltd. | 11/01/2024SE |
| K124035 | 2008K@HOME Hemodialysis MachineONW · Traditional | Fresenius Medical Care North America | 07/03/2013SE |
| K070049 | Fresenius 2008K @Home with Wireless Wetness DetectorONW · Traditional | Fresenius Medical Care North America | 02/03/2011SE |
More from Fresenius Medical Care North America
| 510(k) | Device | Decision |
|---|---|---|
| K123630 | Fresenius Liberty CyclerFKX · Traditional | 09/09/2013SE |
| K120823 | BVM Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsFJK · Traditional | 06/15/2012SE |
| K120505 | Fresenius 2008T Hemodialysis MachineKDI · Special | 03/06/2012SE |
| K101715 | Fresenius 2008T Hemodialysis Machine Model 190573KDI · Traditional | 12/21/2010SE |
Questions and answers
When was Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) cleared by the FDA?
Fresenius 2008K Home Hemodialysis Machine with Wireless Wetness Detector (Wetalert) (K121421) received a 510(k) decision of Substantially Equivalent on January 17, 2013, 248 days after the submission was received.
What is the product code of K121421?
The FDA product code is ONW – Hemodialysis System For Home Use, a Class II (moderate risk) device regulated under 21 CFR 876.5860.