FDA product code QKI: Media, Reproductive, Exempt
QKI is the FDA product code for media, reproductive, exempt. It is a Class II device, regulated under 21 CFR 884.6180 and reviewed by the Obstetrics and Gynecology panel. Devices under QKI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is the class II exempt counterpart of MQL, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Classification
| Field | Value |
|---|---|
| Device name | Media, Reproductive, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 884.6180 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for QKI devices
openFDA lists no recalls for product code QKI.
Frequently asked questions
What is FDA product code QKI?
QKI is the FDA product code for media, reproductive, exempt. It is a Class II device, regulated under 21 CFR 884.6180 and reviewed by the Obstetrics and Gynecology panel.
What device class is QKI?
Class II, regulation 21 CFR 884.6180. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QKI
- Run a recall and safety report across every QKI manufacturer
- Watch product code QKI 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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