FDA product code ODI: Administration Set Docking Station
ODI is the FDA product code for administration set docking station. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under ODI. The average 510(k) review took 198 days (median 198). FDA has posted 1 recall for ODI devices.
Definition
Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
Classification
| Field | Value |
|---|---|
| Device name | Administration Set Docking Station |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every ODI clearance
Top ODI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxa Corp. | 1 | 2007-08-03 |
Most recent ODI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070163 | Baxa Corp. | SWABBABLE CAP, MODEL 60205 | 2007-08-03 | 198 |
Recalls for ODI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code ODI?
ODI is the FDA product code for administration set docking station. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is ODI?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODI?
Across 1 cleared submissions the average was 198 days from receipt to decision (median 198).
Which companies have the most ODI clearances?
Baxa Corp. (1).
Have ODI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code ODI
- Run a recall and safety report across every ODI manufacturer
- Watch product code ODI 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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