# K230602: Hudson RCI® TurboMist™ Nebulizer System

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Oct 31, 2023 after 242 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: 3 generations back to K870027 (1987). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123527: Airlife, Care Fusion (2013) Summary page 5.
- K173367: MC 300* Nebulizer, Trudell Medical International (2018) Summary page 5.

## Indications for use
The Hudson RCI® TurboMist™ Nebulizer is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing.Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer. The patient population includes adult and pediatric (greater than 22 lbs or 10 kg) patients that are spontaneously breathing. The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.

Source page: https://510kreport.com/device/K230602
Methodology: https://510kreport.com/methodology