FDA product code ODN: Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
ODN is the FDA product code for ultrafiltration-controlled nocturnal dialysate delivery system. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under ODN. The average 510(k) review took 136 days (median 136).
Definition
Hemodialysis performed with a high permeability hemodialyzer and an ultrafiltration-controlled system. Nocturnal hemodialysis for patients with end-stage renal disease (chronic dialysis) or acute renal failure (acute dialysis) performed with a high permeability hemodialyzer and an ultrafiltration-controlled system.
Classification
| Field | Value |
|---|---|
| Device name | Ultrafiltration-Controlled Nocturnal Dialysate Delivery System |
| Device class | Class II |
| Regulation | 21 CFR 876.5860 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every ODN clearance
Top ODN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nxstage Medical, Inc. | 2 | 2015-06-04 |
Most recent ODN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150472 | Nxstage Medical, Inc. | NxStage System One | 2015-06-04 | 101 |
| K141752 | Nxstage Medical, Inc. | NXSTAGE SYSTEM ONE | 2014-12-19 | 172 |
Recalls for ODN devices
openFDA lists no recalls for product code ODN.
Frequently asked questions
What is FDA product code ODN?
ODN is the FDA product code for ultrafiltration-controlled nocturnal dialysate delivery system. It is a Class II device, regulated under 21 CFR 876.5860 and reviewed by the Gastroenterology and Urology panel.
What device class is ODN?
Class II, regulation 21 CFR 876.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODN?
Across 2 cleared submissions the average was 136 days from receipt to decision (median 136).
Which companies have the most ODN clearances?
Nxstage Medical, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code ODN
- Run a recall and safety report across every ODN manufacturer
- Watch product code ODN 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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