# K052332: Aerochamber Z-Stat Plus Valved Holding Chamber

- Pathway: 510(k) (Special)
- Applicant: Trudell Medical Intl.
- Decided: Sep 21, 2005 after 26 days
- Product code: NVP (Holding Chambers, 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K140062: FSC Anti-Static Valved Collapsible Holding Chamber (2014), 0 descendants of its own
- K110293: Optichamber Diamond Valved Holding Chamber (2011), 0 descendants of its own
- K072418: Optichamber Advantage Anti-Static Valved Holding Chamber (2007), 0 descendants of its own

## Indications for use
The AeroChamber Z-STAT Plus TM Valved Holding Chamber is intended to be used by patients who are under the care or 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/K052332
Methodology: https://510kreport.com/methodology