# K991685: Halolite Aad System with Dedicated Compressor

- Pathway: 510(k) (Traditional)
- Applicant: Medic-Aid, Ltd.
- Decided: Aug 13, 1999 after 88 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: 2 generations back to K933535 (1994). 4 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981772: Halolite Aad System, Medic-Aid, Ltd. (1998) Summary page 1.
- K950867: Medi - Pump, Thomas Industries (1995) Summary page 1.

## Most influential descendants
- K030747: Prodose Aad System (2004), 10 descendants of its own
- 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

## Indications for use
A HaloLite Adaptive Aerosol Delivery, (AAD) system, a handheld nebulizer system including a dedicated compressor is designed to aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment.

Source page: https://510kreport.com/device/K991685
Methodology: https://510kreport.com/methodology