# K140919: Respiconnect Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Trudell Medical Int'L
- Decided: Aug 15, 2014 after 127 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 K926301 (1993). 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)
- K926301: Ace Aerosol Enhancer, Hand Held Oral Inhalation CO, Dhd Diemolding Healthcare Div. (1993) Summary page 4.

## Indications for use
The RespiConnect Adapter is designed to be used with RESPIMAT™ SOFT MIST INHALERS to facilitate the delivery of bronchodilator aerosol medication to mechanically ventilated patients. The single patient use adapter is intended to be left in the inspiratory limb of a 22 mm ventilator circuit.

Source page: https://510kreport.com/device/K140919
Methodology: https://510kreport.com/methodology