# K210558: LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Thayer Medical Corporation
- Decided: Apr 1, 2022 after 400 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 K993101 (2000). 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)
- K160109: Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber, Thayer Medical Corporation (2017) Summary page 4.

## Indications for use
The LiteAire is a collapsible, disposable dual-valved holding chamber designed to aid in the delivery of aerosolized medications delivered via a pressurized metered dose inhaler (MDI). The LiteAire features a standard port designed for compatibility with standard MDI mouthpieces. It is a non-sterile device for single-patient use. The LiteAire is intended to be used by adults, adolescents and children ages 5 and up who are able to use a holding chamber without the aid of a mask and who are under the care or treatment of a physician or licensed healthcare professional.

Source page: https://510kreport.com/device/K210558
Methodology: https://510kreport.com/methodology