# K203400: Corrugated tube with mouthpiece accessory

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical International
- Decided: Jun 14, 2021 after 207 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: 2 generations back to K926055 (1993). 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)
- K173367: MC 300* Nebulizer, Trudell Medical International (2018) Summary page 4.

## Indications for use
The corrugated tube is an accessory to the MC 300 ® Nebulizer. It is designed to work in conjunction with the MC 300 ® Nebulizer to extend the patient interface away from the nebulizer. The accessory is a single patient use device that is intended to be used with either mouthpiece or mask for pediatric (ages 2 years and above) and adult patients, who are under the care of a licensed healthcare provider or physician.

Source page: https://510kreport.com/device/K203400
Methodology: https://510kreport.com/methodology