# K053605: Aeroeclipse II Breath Actuated Nebulizer

- Pathway: 510(k) (Special)
- Applicant: Trudell Medical Intl.
- Decided: Feb 27, 2006 after 62 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K242354: AllNEB (2025), 0 descendants of its own
- K200063: AeroEclipse* ONE BAN (2020), 0 descendants of its own

## Indications for use
The AeroEclipse® II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

Source page: https://510kreport.com/device/K053605
Methodology: https://510kreport.com/methodology