# K173825: MC 300R* Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical International
- Decided: May 2, 2018 after 135 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 K080926 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080926: Aeroeclipse Durable Breath Actuated Nebulizer, Trudell Medical Intl. (2008) Summary page 4.

## Indications for use
The nebulizer is intended to be used with pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician. The device is designed to aerosolize prescribed medication for inhalation by a patient in the hospital, clinic or home care environment. The nebulizer is a single patient use device.

Source page: https://510kreport.com/device/K173825
Methodology: https://510kreport.com/methodology