# K992917: Aerochamber Plus Valved Holding Chamber

- Pathway: 510(k) (Special)
- Applicant: Trudell Medical Int'L
- Decided: Sep 14, 1999 after 15 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 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
- K080100: Watchhaler (2008), 0 descendants of its own
- K032809: Hospital Spacer (2003), 0 descendants of its own
- K020944: Vortex Valved Holding Chamber (2002), 0 descendants of its own

## Indications for use
The “AeroChamber® Pjus Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by used by these patients to administer aerosolized medication from most pressurized Metered Dose. [nhalers, 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/K992917
Methodology: https://510kreport.com/methodology