# K992831: Aeroneb II, Model Apn 200

- Pathway: 510(k) (Traditional)
- Applicant: Aerogen, Inc.
- Decided: Aug 25, 2000 after 368 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 K970010 (1997). 1 ancestor in all.
11 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970010: FPT Nebulizer, Fluid Propulsion Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- K033833: Eflow Electronic Inhaler/Nebulizer (2004), 10 descendants of its own
- K072670: Modification to: Eflow Electronic Inhaler/Nebulizer (2007), 5 descendants of its own
- K100380: Altera Nebulizer System, Model 678G1002 (2010), 4 descendants of its own
- K112859: Erapid Nebulizer System (2012), 3 descendants of its own
- K072019: AKITA2 Apixneb (2007), 3 descendants of its own

## Indications for use
The AeroNeb™ |i Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.

Source page: https://510kreport.com/device/K992831
Methodology: https://510kreport.com/methodology