# K242354: AllNEB

- Pathway: 510(k) (Traditional)
- Applicant: Enchant Tek Co., Ltd.
- Decided: Apr 29, 2025 after 264 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 5.

## Indications for use
AIINEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AIINEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AIINEB is to be used at home or in hospitals and clinics.

Source page: https://510kreport.com/device/K242354
Methodology: https://510kreport.com/methodology