# K993101: Liteaire

- Pathway: 510(k) (Traditional)
- Applicant: Thayer Medical Corp.
- Decided: Oct 26, 2000 after 406 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K160109: Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber (2017), 1 descendant of its own
- K210558: LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber (2022), 0 descendants of its own

## Indications for use
The LiteAire is a collapsible, disposable accessory device for use with a metered dose inhaler (MDI) canister and nozzle/mouthpiece provided by the MDI drug manufacturer. It is designed to be used with virtually all MDI nozzles/mouthpieces. The LiteAire is a dual-valved holding chamber designed to serve three-major functions: e To reduce the amount of MDI medication deposited in the patient’s mouth and throat, thus reducing the potential for unwanted local or systemic side effects. ¢ To ease the problems that many patients have in synchronizing actuation of the MDI canister with the start of inhalation. o To retain a significant portion of the MDI drug plume until the patient’s next inhalation, in cases where actuation and inhalation are asynchronous. The LiteAire is a non-sterile device for single-patient use.

Source page: https://510kreport.com/device/K993101
Methodology: https://510kreport.com/methodology