# K223100: Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jun 27, 2023 after 270 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 K880473 (1988). 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)
- K880473: Aero-Mist Nebulizer Heater, Pegasus Research Corp. (1988) Summary page 4.

## Indications for use
The Hudson RCI AQUATHERM® Ill Plus External Adjustable Electronic Heater is designed for use with the Hudson RCI Nebulizer Adaptor and the AQUAPAK® system to provide continuous heated aerosol for respiratory applications.

Source page: https://510kreport.com/device/K223100
Methodology: https://510kreport.com/methodology