# K090065: Aerochamber Mini Ventilation Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical Intl.
- Decided: Apr 9, 2009 after 90 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- Recalls of this device: none
- 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.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AeroChamber mini Ventilation Chamber is a single patient, disposable device, intended to be used for the administration of metered dose inhaler medication prescribed by a physician or health care professional. The device is intended for use with patients on mechanical ventilation via resuscitation bag or ventilator circuit. The intended environments for use include the home, hospitals and clinics.

Source page: https://510kreport.com/device/K090065
Methodology: https://510kreport.com/methodology