# K032170: Transneb Compressor W/Nebulizer, Model 5000

- Pathway: 510(k) (Traditional)
- Applicant: Medical Industries America, Inc.
- Decided: May 28, 2004 after 317 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). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 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.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.
- K021443: 56 Series Jet Nebulizer, Project Marketing (2002) Summary page 1.

## Most influential descendants
- K042483: Invacare Pro, Compact and Portable Desktop (2005), 2 descendants of its own
- K072163: Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 (2008), 0 descendants of its own
- K062014: Families of Master Neb, Primo Neb, SC03, Neb Aid, 4.2.Neb, Q03, FJ03, and Walkie-Neb (2007), 0 descendants of its own

## Indications for use
The TransNeb compressor/nebulizer includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used with a venturi (pneumatic nebulizer) to convert certain inhaled drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

Source page: https://510kreport.com/device/K032170
Methodology: https://510kreport.com/methodology