# P080009: Sedasys Computer-Assisted Personalized Sedation System

- Pathway: PMA
- Applicant: Scott Laboratories, Inc.
- Decided: May 3, 2013 after 1,865 days
- Product code: PDR (Computer-Assisted Personalized Sedation System)
- Device class: 3
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 13, 2015 · Class I · Z-2374-2015: Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.

Source page: https://510kreport.com/device/P080009
Methodology: https://510kreport.com/methodology