# K110860: Comp a-I-R

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: Sep 2, 2011 after 157 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 K914836 (1992). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060811: Omron Compressor Systems, Models NE-C28,NE-C30, Omron Healthcare, Inc. (2006) Summary page 1.

## Most influential descendants
- K243244: Heated Breathing Tube (2025), 0 descendants of its own
- K243468: Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) (2025), 0 descendants of its own
- K141140: Comp a-I-R (2014), 0 descendants of its own

## Indications for use
The NE-C801 Nebulizer Compressor System is intended to provide air to the pneumatic nebulizer in order to aerosolize medications for inhalation by the patient for respiratory disorders. The system is designed for use with pediatric (defined by the prescribed medication) and adult patients in the home, hospital, and sub-acute settings.

Source page: https://510kreport.com/device/K110860
Methodology: https://510kreport.com/methodology