FDA product code QKS: Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led
QKS is the FDA product code for inhaler, metered dose or dry powder, cder or cber led. It is a Not classified device, reviewed by the Anesthesiology panel. Devices under QKS reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
Metered Dose Inhaler and Dry Powder Inhalers are products that deliver drug substance to the site of action through the inhalation route
Classification
| Field | Value |
|---|---|
| Device name | Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led |
| Device class | Not classified |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
Recalls for QKS devices
openFDA lists no recalls for product code QKS.
Frequently asked questions
What is FDA product code QKS?
QKS is the FDA product code for inhaler, metered dose or dry powder, cder or cber led. It is a Not classified device, reviewed by the Anesthesiology panel.
What device class is QKS?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code QKS
- Run a recall and safety report across every QKS manufacturer
- Watch product code QKS 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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