FDA product code PDR: Computer-Assisted Personalized Sedation System
PDR is the FDA product code for computer-assisted personalized sedation system. It is a Class III device, reviewed by the Anesthesiology panel. Devices under PDR 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 PDR devices.
Definition
Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.
Classification
| Field | Value |
|---|---|
| Device name | Computer-Assisted Personalized Sedation System |
| Device class | Class III |
| Review panel | AN — Anesthesiology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for PDR devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-05-13.
Frequently asked questions
What is FDA product code PDR?
PDR is the FDA product code for computer-assisted personalized sedation system. It is a Class III device, reviewed by the Anesthesiology panel.
What device class is PDR?
Class III. Typical premarket route: PMA.
Have PDR devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code PDR
- Run a recall and safety report across every PDR manufacturer
- Watch product code PDR 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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