FDA product code QLM: Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool
QLM is the FDA product code for intensive care unit, respiratory failure and hemodynamic instability tool. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under QLM reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
To be used by healthcare providers in the Intensive Care Unit (ICU) for adult patients for the computation of patient status indices as an adjunct to patient monitoring during the declared public health emergency.
Classification
| Field | Value |
|---|---|
| Device name | Intensive Care Unit, Respiratory Failure And Hemodynamic Instability Tool |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QLM devices
openFDA lists no recalls for product code QLM.
Frequently asked questions
What is FDA product code QLM?
QLM is the FDA product code for intensive care unit, respiratory failure and hemodynamic instability tool. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is QLM?
Not classified. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QLM
- Run a recall and safety report across every QLM manufacturer
- Watch product code QLM 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.