FDA product code QYF: Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)
QYF is the FDA product code for neonatal icu continuous non-invasive blood pressure monitor (includes alarms). It is a Class II device, regulated under 21 CFR 870.1130 and reviewed by the Cardiovascular panel. Devices under QYF reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
The Neonatal ICU continuous non-invasive blood pressure monitor is a prescription device used by medical professionals that measures non-invasive continuous cuffless blood pressure in neonates in the NICU who have a palpable pulse. The device requires calibration. This device is intended for use in conjunction with SpO2 monitoring and is not indicated for ambulatory monitoring.
Classification
| Field | Value |
|---|---|
| Device name | Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms) |
| Device class | Class II |
| Regulation | 21 CFR 870.1130 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for QYF devices
openFDA lists no recalls for product code QYF.
Frequently asked questions
What is FDA product code QYF?
QYF is the FDA product code for neonatal icu continuous non-invasive blood pressure monitor (includes alarms). It is a Class II device, regulated under 21 CFR 870.1130 and reviewed by the Cardiovascular panel.
What device class is QYF?
Class II, regulation 21 CFR 870.1130. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QYF
- Run a recall and safety report across every QYF manufacturer
- Watch product code QYF 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.