FDA product code QJT: Rigid Sterilization Container With Software
QJT is the FDA product code for rigid sterilization container with software. It is a Class II device, regulated under 21 CFR 880.6855 and reviewed by the General Hospital panel. Devices under QJT reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
The rigid sterilization container with software is intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility until used. The rigid sterilization container with software is designed for use with high-vacuum or pulse-vacuum steam sterilization systems.
Classification
| Field | Value |
|---|---|
| Device name | Rigid Sterilization Container With Software |
| Device class | Class II |
| Regulation | 21 CFR 880.6855 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Recalls for QJT devices
openFDA lists no recalls for product code QJT.
Frequently asked questions
What is FDA product code QJT?
QJT is the FDA product code for rigid sterilization container with software. It is a Class II device, regulated under 21 CFR 880.6855 and reviewed by the General Hospital panel.
What device class is QJT?
Class II, regulation 21 CFR 880.6855. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QJT
- Run a recall and safety report across every QJT manufacturer
- Watch product code QJT 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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