# K051222: AV-S Anaesthesia Ventilator

- Pathway: 510(k) (Traditional)
- Applicant: Penlon Limited
- Decided: Sep 23, 2005 after 134 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930017 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010317: AV 800 Ventilator, Penlon, Ltd. (2001) Summary page 1.
- K010318: Prima Oxygen Monitor, Penlon, Ltd. (2001) Summary page 1.
- K960964: Ohmeda 7900 Anesthesia Ventilator, Ohmeda Medical (1996) Summary page 1.
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements, Datex-Ohmeda, Inc. (2003) Summary page 1.

## Indications for use
The AV-S Anaesthesia Ventilator is intended to provide continuous mechanical ventilatory support during general anaesthesia. The ventilator is a restricted medical device intended for use by qualified trained personnel, i.e. Nurses and Technicians under the direction of a Physician. Specifically the ventilator is indicated for use by both adult and pediatric patients. The AV-S Anaesthesia ventilator is a prescription device and the labelling indicates this.

Source page: https://510kreport.com/device/K051222
Methodology: https://510kreport.com/methodology