FDA product code ONW: Hemodialysis System For Home Use
ONW is the FDA product code for hemodialysis system for home use. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under ONW, 1 in the last five years, from 3 different applicants. The average 510(k) review took 504 days (median 218); 92 days on average over the last three years. FDA has posted 4 recalls for ONW devices.
Definition
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Classification
| Field | Value |
|---|---|
| Device name | Hemodialysis System For Home Use |
| Device class | Class II |
| Regulation | 21 CFR 876.5860 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for ONW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 92 |
Compare with all 510(k) review times · Search every ONW clearance
Top ONW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fresenius Medical Care North America | 2 | 2013-07-03 |
| Quanta Dialysis Technologies, Ltd. | 1 | 2024-11-01 |
| Fresenius Medical Care North America, Design Cente | 1 | 2013-01-17 |
Most recent ONW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242269 | Quanta Dialysis Technologies, Ltd. | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) | 2024-11-01 | 92 |
| K124035 | Fresenius Medical Care North America | 2008K@HOME HEMODIALYSIS MACHINE | 2013-07-03 | 187 |
| K121421 | Fresenius Medical Care North America, Design Cente | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) | 2013-01-17 | 248 |
| K070049 | Fresenius Medical Care North America | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | 2011-02-03 | 1491 |
Recalls for ONW devices
4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-29.
Frequently asked questions
What is FDA product code ONW?
ONW is the FDA product code for hemodialysis system for home use. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel.
What device class is ONW?
Class II, regulation 21 CFR 876.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code ONW?
Across 4 cleared submissions the average was 504 days from receipt to decision (median 218).
Which companies have the most ONW clearances?
Fresenius Medical Care North America (2); Quanta Dialysis Technologies, Ltd. (1); Fresenius Medical Care North America, Design Cente (1).
Have ONW devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2013-08-29.
Next steps
- Run an FDA pathway report with predicate devices for product code ONW
- Run a recall and safety report across every ONW manufacturer
- Watch product code ONW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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