# K141353: Hudson Rci Aquapak Humidifier Adaptor

- Pathway: 510(k) (Special)
- Applicant: Teleflexmedical, Inc.
- Decided: Aug 1, 2014 after 70 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- 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 K780562 (1978). 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)
- K780562: Aquapak Prefilled Humidifier, Respiratory Care, Inc. (1978) Summary page 5.
- K833974: Aquapak 020 Humidifier Adapter, Respiratory Care, Inc. (1983) Summary page 5.

## Indications for use
The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.

Source page: https://510kreport.com/device/K141353
Methodology: https://510kreport.com/methodology
