# K131790: A9800 Anesthesia Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Oricare, Inc.
- Decided: May 9, 2014 after 325 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K902859 (1991). 113 ancestors in all.
No later device cites it as a predicate yet.
9 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123125: GE Datex-Ohmeda Avance CS2, Datex-Ohmeda, Inc. (2013) Summary page 1.
- K123211: A5 Anesthesia Delivery System, Datascope Corp., Patient Monitoring Division (2013) Summary page 1.
- K042607: Primus US, Draeger Medical, Inc. (2004) Summary page 1.

## Indications for use
The A9800 Anesthesia Workstation provides general inhalation anesthesia and ventilatory support for adolescents to adults in an operating room environment. The device is indicated for volume or pressure control ventilation.

Source page: https://510kreport.com/device/K131790
Methodology: https://510kreport.com/methodology