# K200063: AeroEclipse* ONE BAN

- Pathway: 510(k) (Abbreviated)
- Applicant: Trudell Medical International
- Decided: Jul 17, 2020 after 186 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 K053605 (2006). 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)
- K053605: Aeroeclipse II Breath Actuated Nebulizer, Trudell Medical Intl. (2006) Summary page 4.

## Indications for use
The AeroEclipse®* ONE BAN is intended to be used with adults and pediatric patients over 5 years old, 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/K200063
Methodology: https://510kreport.com/methodology