FDA product code QTB: Nitric Oxide Generator And Delivery System
QTB is the FDA product code for nitric oxide generator and delivery system. It is a Class III device, reviewed by the Anesthesiology panel. Devices under QTB reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
The system is intended for generation and delivery of nitric oxide (NO) for use in conjunction with ventilatory support and other appropriate agents to produce, at point of care, and deliver nitric oxide (NO) to treat term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with pulmonary hypertension. The system includes an integrated backup NO delivery system and gas analyzers with an alarm for monitoring of delivered NO, nitrogen dioxide (NO2), and oxygen (O2).
Classification
| Field | Value |
|---|---|
| Device name | Nitric Oxide Generator And Delivery System |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for QTB devices
openFDA lists no recalls for product code QTB.
Frequently asked questions
What is FDA product code QTB?
QTB is the FDA product code for nitric oxide generator and delivery system. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is QTB?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QTB
- Run a recall and safety report across every QTB manufacturer
- Watch product code QTB 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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