# K042991: I-Neb Aad System

- Pathway: 510(k) (Traditional)
- Applicant: Profile Therapeutics Plc
- Decided: Sep 23, 2005 after 326 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: 4 generations back to K933535 (1994). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030747: Prodose Aad System, Profile Therapeutics Plc (2004) Summary page 1.
- K991685: Halolite Aad System with Dedicated Compressor, Medic-Aid, Ltd. (1999) Summary page 1.
- K923024: NE-U04/NE U04F, Omron Healthcare, Inc. (1992) Summary page 1.

## Most influential descendants
- K100380: Altera Nebulizer System, Model 678G1002 (2010), 4 descendants of its own
- K112859: Erapid Nebulizer System (2012), 3 descendants of its own
- K223840: eRapid Nebulizer System (2023), 1 descendant of its own
- K251572: eRapid with eTrack System (2025), 0 descendants of its own
- K162785: Velox Nebulizer System (2017), 0 descendants of its own

## Indications for use
The intended purpose of the I-neb AAD System is that is it is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication approved for use with the I-neb AAD System for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.

Source page: https://510kreport.com/device/K042991
Methodology: https://510kreport.com/methodology