# K060811: Omron Compressor Systems, Models NE-C28,NE-C30

- Pathway: 510(k) (Traditional)
- Applicant: Omron Healthcare, Inc.
- Decided: May 25, 2006 after 62 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 K914836 (1992). 1 ancestor in all.
4 later devices descend from it; 1 cites 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)
- K914836: Omron Compressor Nebulizer- Model NE-C09, Omron Healthcare, Inc. (1992) Summary page 1.

## Most influential descendants
- K110860: Comp a-I-R (2011), 3 descendants of its own
- 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 Omron Compressor Nebulizer Systems include a compressor and nebulizer, Model NE-C28 uses a DC powered compressor and Model NE-C30 can operate with AC/DC power. The electrically powered compressor provides compressed air to the supplied pneumatic nebulizer to aerosolize drugs for inhalation by the patient. The nebulizer is driven by the integral air compressor. The device may be used with pediatric and adult patients in the home, hospital, and sub-acute care settings. It is not intended for use with Pentamidine.

Source page: https://510kreport.com/device/K060811
Methodology: https://510kreport.com/methodology