FDA product code OEI: Drainage Catheter With Antibiotic
OEI is the FDA product code for drainage catheter with antibiotic. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under OEI. The average 510(k) review took 398 days (median 398). FDA has posted 2 recalls for OEI devices.
Definition
A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.
Classification
| Field | Value |
|---|---|
| Device name | Drainage Catheter With Antibiotic |
| Device class | Class II |
| Regulation | 21 CFR 878.4780 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OEI clearance
Top OEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bacterin International, Inc. | 1 | 2007-11-28 |
Most recent OEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063245 | Bacterin International, Inc. | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN | 2007-11-28 | 398 |
Recalls for OEI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-05-15.
Frequently asked questions
What is FDA product code OEI?
OEI is the FDA product code for drainage catheter with antibiotic. It is a Class II device, regulated under 21 CFR 878.4780 and reviewed by the General and Plastic Surgery panel.
What device class is OEI?
Class II, regulation 21 CFR 878.4780. Typical premarket route: 510(k).
How long does a 510(k) take for product code OEI?
Across 1 cleared submissions the average was 398 days from receipt to decision (median 398).
Which companies have the most OEI clearances?
Bacterin International, Inc. (1).
Have OEI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2014-05-15.
Next steps
- Run an FDA pathway report with predicate devices for product code OEI
- Run a recall and safety report across every OEI manufacturer
- Watch product code OEI 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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