# K032972: Aerochamber Max Valved Holding Chamber

- Pathway: 510(k) (Special)
- Applicant: Trudell Medical Intl.
- Decided: Jan 14, 2004 after 112 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K100285: Litetouch Mask (2010), 0 descendants of its own

## Indications for use
The AeroChamber MAX TM Valved Holding Chamber is intended to be used by patients who are under the care of treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Source page: https://510kreport.com/device/K032972
Methodology: https://510kreport.com/methodology