# K100285: Litetouch Mask

- Pathway: 510(k) (Traditional)
- Applicant: Respironics New Jersey, Inc.
- Decided: Jun 29, 2010 after 148 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 K992917 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032972: Aerochamber Max Valved Holding Chamber, Trudell Medical Intl. (2004) Summary page 2.
- K992917: Aerochamber Plus Valved Holding Chamber, Trudell Medical Int'L (1999) Summary page 2.

## Indications for use
The LiteTouch medium mask for ages 1-5 is to be used with OptiChamber Advantage Valved Holding Chambers. The mask is intended to be used to help administer aerosolized medication from most pressurized metered dose inhalers used with valved holding chambers as prescribed by a physician or health care professional. The intended environments for use include homes, hospitals, and clinics.

Source page: https://510kreport.com/device/K100285
Methodology: https://510kreport.com/methodology