# K141214: Aquapak Nebulizer Adaptors/Reservoirs

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Dec 18, 2014 after 220 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 K962534 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962534: Thera-Mist Nebulizer Model-P3000, Pegasus Research Corp. (1997) Summary page 5.

## Most influential descendants
- K153010: Hudson RCI AquaPak Sterile Prefilled Nebulizers (2016), 0 descendants of its own

## Indications for use
Hudson RCI® AquaPak® 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/K141214
Methodology: https://510kreport.com/methodology