# K070411: Amsure Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Oct 1, 2007 after 231 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 K930525 (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)
- K930525: Micro Mist (TM) Nebulizer, Hudson Respiratory Care, Inc. (1993) Summary page 1.

## Indications for use
The AMSURE® Nebulizer is intended for the administration of various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs for nebulization, under the direction of a physician. It can be used for both pediatric and adult patient populations.

Source page: https://510kreport.com/device/K070411
Methodology: https://510kreport.com/methodology