FDA product code ODX: Autonomous Extracorporeal Blood Leak Detector/Alarm
ODX is the FDA product code for autonomous extracorporeal blood leak detector/alarm. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under ODX. The average 510(k) review took 195 days (median 209). FDA has posted 1 recall for ODX devices.
Definition
To detect the presence of blood leaking from an extracorporeal connection or needle site in hemodialysis patients and alert the user or attending staff. The device detects colormetric, chemical, or light modulation caused by exposure to leaking blood.
Classification
| Field | Value |
|---|---|
| Device name | Autonomous Extracorporeal Blood Leak Detector/Alarm |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ODX clearance
Top ODX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Redsense Medical AB | 4 | 2013-11-22 |
Most recent ODX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130554 | Redsense Medical AB | REDSENSE ALARM SYSTEM | 2013-11-22 | 263 |
| K103242 | Redsense Medical AB | REDSENSE-ALARM UNIT AND SENSOR | 2011-02-10 | 100 |
| K092955 | Redsense Medical AB | REDSENSE-HOME USE | 2010-05-10 | 227 |
| K071013 | Redsense Medical AB | REDSENSE | 2007-10-18 | 191 |
Recalls for ODX devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-08-11.
Frequently asked questions
What is FDA product code ODX?
ODX is the FDA product code for autonomous extracorporeal blood leak detector/alarm. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is ODX?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODX?
Across 4 cleared submissions the average was 195 days from receipt to decision (median 209).
Which companies have the most ODX clearances?
Redsense Medical AB (4).
Have ODX devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code ODX
- Run a recall and safety report across every ODX manufacturer
- Watch product code ODX 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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