# K041781: Ventilair II Medical Air Compressor

- Pathway: 510(k) (Traditional)
- Applicant: Hamilton Medical AG
- Decided: Mar 14, 2005 after 256 days
- Product code: BTI (Compressor, Air, Portable)
- Device class: 2
- Regulation: 21 CFR 868.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920954 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982789: Medical Air Compressor, Model # 8413419, Drager, Inc. (1998) Summary page 2.
- K920954: Air Star, Infrasonics Corp. (1992) Summary page 2.
- (no number) Bennett MC-2 Mobile Air Compressor: named in the summary without a submission number

## Indications for use
The Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.

Source page: https://510kreport.com/device/K041781
Methodology: https://510kreport.com/methodology