FDA product code QSF: Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents
QSF is the FDA product code for software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents. It is a Class III device, reviewed by the Anesthesiology panel. Devices under QSF reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for QSF devices, 1 initiated in the last five years.
Definition
The software feature is indicated for use with the anesthesia system to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that the clinician sets during an anesthetic procedure, by making multiple, limited adjustments to the fresh gas composition and total flow. The software feature is indicated for adult patients, 18 years of age and older. The anesthesia system and the software feature are intended for prescription use only.
Classification
| Field | Value |
|---|---|
| Device name | Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for QSF devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-07-12.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code QSF?
QSF is the FDA product code for software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is QSF?
Class III. Typical premarket route: PMA.
Have QSF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-07-12.
Next steps
- Run an FDA pathway report with predicate devices for product code QSF
- Run a recall and safety report across every QSF manufacturer
- Watch product code QSF 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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