# K153010: Hudson RCI AquaPak Sterile Prefilled Nebulizers

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Jul 26, 2016 after 286 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 K962534 (1997). 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)
- K141214: Aquapak Nebulizer Adaptors/Reservoirs, Teleflexmedical, Inc. (2014) Summary page 4.

## Indications for use
The Hudson RCI® AquaPak® Sterile Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient’s breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.

Source page: https://510kreport.com/device/K153010
Methodology: https://510kreport.com/methodology