# K030747: Prodose Aad System

- Pathway: 510(k) (Abbreviated)
- Applicant: Profile Therapeutics Plc
- Decided: Apr 22, 2004 after 409 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: 3 generations back to K933535 (1994). 6 ancestors in all.
10 later devices descend from it; 2 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981772: Halolite Aad System, Medic-Aid, Ltd. (1998) Summary page 1.
- K991685: Halolite Aad System with Dedicated Compressor, Medic-Aid, Ltd. (1999) Summary page 1.
- K935693: Autoneb Breath Actuated Controller and Accessory Kit, Vortran Medical Technology 1, Inc. (1994) Summary page 1.
- K990801: Minimed 508 Insulin Pump, Medtronic Minimed (1999) Summary page 1.

## Most influential descendants
- K042991: I-Neb Aad System (2005), 6 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
- K223840: eRapid Nebulizer System (2023), 1 descendant of its own

## Indications for use
A jet nebulizer system designed to aerosolize commonly prescribed liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institutions or hospital environment.

Source page: https://510kreport.com/device/K030747
Methodology: https://510kreport.com/methodology