# K080100: Watchhaler

- Pathway: 510(k) (Traditional)
- Applicant: Activaero America, Inc.
- Decided: Jun 30, 2008 after 168 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
Longest line of descent: 2 generations back to K962822 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992917: Aerochamber Plus Valved Holding Chamber, Trudell Medical Int'L (1999) Summary page 1.
- K070674: Aerochamber Plus Anti-Static Valved Holding Chamber with Flow-VU Inspiratory Flow Indicator, Trudell Medical Intl. (2007) Summary page 1.
- K042546: Funhaler, Model FH 101, Infamed, Ltd. (2005) Summary page 1.

## Indications for use
The Watchhaler is a holding chamber intended to administer aerosolized medication with a Metered Dose Inhaler. For pediatric patients (3 years and older). The environment of use includes home care, nursing homes, sub-acute institutions, and hospitals

Source page: https://510kreport.com/device/K080100
Methodology: https://510kreport.com/methodology