FDA product code OBK: Port, Protector/Cushion
OBK is the FDA product code for port, protector/cushion. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OBK. The average 510(k) review took 248 days (median 248). FDA has posted 1 recall for OBK devices.
Definition
Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Classification
| Field | Value |
|---|---|
| Device name | Port, Protector/Cushion |
| Device class | Class II |
| Regulation | 21 CFR 880.5965 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OBK clearance
Top OBK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inspired Ideas, Incorporated | 1 | 2007-04-09 |
Most recent OBK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K062261 | Inspired Ideas, Incorporated | FOAM RING PORT PROTECTOR | 2007-04-09 | 248 |
Recalls for OBK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-09-10.
Frequently asked questions
What is FDA product code OBK?
OBK is the FDA product code for port, protector/cushion. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel.
What device class is OBK?
Class II, regulation 21 CFR 880.5965. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBK?
Across 1 cleared submissions the average was 248 days from receipt to decision (median 248).
Which companies have the most OBK clearances?
Inspired Ideas, Incorporated (1).
Have OBK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code OBK
- Run a recall and safety report across every OBK manufacturer
- Watch product code OBK 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times