# K042546: Funhaler, Model FH 101

- Pathway: 510(k) (Abbreviated)
- Applicant: Infamed, Ltd.
- Decided: Jan 3, 2005 after 105 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
Longest line of descent: 1 generation back to K962822 (1996). 1 ancestor in all.
2 later devices descend from it; 2 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)
- K962822: Optichamber, Healthscan Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K080100: Watchhaler (2008), 0 descendants of its own
- K072822: Funhaler, Model V-201E (2007), 0 descendants of its own

## Indications for use
Funhaler is intended for use primarily in the pediatric population. Funhaler is used in combination with a Metered Dose Inhaler for respiratory drug delivery.

Source page: https://510kreport.com/device/K042546
Methodology: https://510kreport.com/methodology