FDA product code LSZ: Ventilator, High Frequency
LSZ is the FDA product code for ventilator, high frequency. It is a Class III device, reviewed by the Anesthesiology panel. Devices under LSZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 7 recalls for LSZ devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, High Frequency |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LSZ devices
7 product recalls in 5 recall events; 3 initiated in the last five years and 1 still open. Most recent: 2023-10-27.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code LSZ?
LSZ is the FDA product code for ventilator, high frequency. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is LSZ?
Class III. Typical premarket route: PMA.
Have LSZ devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2023-10-27.
Next steps
- Run an FDA pathway report with predicate devices for product code LSZ
- Run a recall and safety report across every LSZ manufacturer
- Watch product code LSZ 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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