FDA product code QKH: Assisted Reproduction Laminar Flow Workstation
QKH is the FDA product code for assisted reproduction laminar flow workstation. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel. Devices under QKH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
This product code is a class II exempt counterpart of MQG, 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 | Assisted Reproduction Laminar Flow Workstation |
| Device class | Class II |
| Regulation | 21 CFR 884.6120 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Recalls for QKH devices
openFDA lists no recalls for product code QKH.
Frequently asked questions
What is FDA product code QKH?
QKH is the FDA product code for assisted reproduction laminar flow workstation. It is a Class II device, regulated under 21 CFR 884.6120 and reviewed by the Obstetrics and Gynecology panel.
What device class is QKH?
Class II, regulation 21 CFR 884.6120. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QKH
- Run a recall and safety report across every QKH manufacturer
- Watch product code QKH 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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