# K231058: Hudson RCI® AddiPak® Unit Dose Vial

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Jan 4, 2024 after 266 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: 4 generations back to K870332 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142153: Hudson Rci Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, 3ML;5ML;15ML, Teleflexmedical, Inc. (2015) Summary page 5.

## Indications for use
The AddiPak® Unit Dose Vial may be used in conjunction with a non-ventilator nebulizer for lavage therapy, or for tracheal irrigation. These products are single-use, disposable, and intended for inhalation only.

Source page: https://510kreport.com/device/K231058
Methodology: https://510kreport.com/methodology