# K102719: Atlantean Trigger Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Atlantean Corporation
- Decided: Jul 1, 2011 after 283 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 Atlantean Trigger Nebulizer is used to administer various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs upon the specific direction by a physician. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Source page: https://510kreport.com/device/K102719
Methodology: https://510kreport.com/methodology