FDA product code OCI: Indicator, Physical/Chemical, Storage Temperature
OCI is the FDA product code for indicator, physical/chemical, storage temperature. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under OCI. The average 510(k) review took 239 days (median 239).
Definition
The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile.
Classification
| Field | Value |
|---|---|
| Device name | Indicator, Physical/Chemical, Storage Temperature |
| Device class | Class II |
| Regulation | 21 CFR 880.2800 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top OCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Temptime Corporation | 1 | 2007-08-15 |
Most recent OCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K063759 | Temptime Corporation | HEATMARKER TIME TEMPERATURE INDICATOR | 2007-08-15 | 239 |
Recalls for OCI devices
openFDA lists no recalls for product code OCI.
Frequently asked questions
What is FDA product code OCI?
OCI is the FDA product code for indicator, physical/chemical, storage temperature. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel.
What device class is OCI?
Class II, regulation 21 CFR 880.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCI?
Across 1 cleared submissions the average was 239 days from receipt to decision (median 239).
Which companies have the most OCI clearances?
Temptime Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OCI
- Run a recall and safety report across every OCI manufacturer
- Watch product code OCI 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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