# K120075: AM-6000 Anesthesia Machine

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Jan 26, 2012 after 16 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: 7 generations back to K930017 (1994). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080175: Navigator Anesthesia Delivery System, Model 0998-00-3024-01, Datascope Corp., Patient Monitoring Division (2008) Summary page 2.

## Indications for use
The AM-6000 Anesthesia machine is intended for general anesthesia use. The AM-6000 Anesthesia machine will delivery operator set concentrations of Oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. AM-6000 Anesthesia machine is also intended to allow for the provision of manual ventilation. Intended operator: The AM-6000 Anesthesia machine is intended for use by Healthcare professionals who are trained in the administration of anesthesia. Intended Patient Populations: The AM-6000 Anesthesia machine is intended for use on the neonatal to adult patient populations in all ventilation modes. Intended Use Environment: The AM-6000 Anesthesia machine is intended to be used in the environments where anesthesia is to be administered by Healthcare professionals trained in administering anesthesia.

Source page: https://510kreport.com/device/K120075
Methodology: https://510kreport.com/methodology