ONW
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hemodialysis System For Home Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- To treat and provide hemodialysis therapy at home for chronic renal failure patients.
- Adverse events (MAUDE)
- 2013: 8 · 2014: 35 · 2015: 28 · 2016: 19 · 2017: 11 · 2018: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 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 |
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Every clearance here is in the API, with alerts when new ones post.