# K982181: Trumist Breath Actuated Disposable Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical
- Decided: Jan 8, 1999 after 200 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The “TruMist™ Breath Actuated Disposable Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care professional or physician. The device is intended to by used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Source page: https://510kreport.com/device/K982181
Methodology: https://510kreport.com/methodology