# K061381: LC Star with Nasal Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Pari Innovative Manufacturers, Inc.
- Decided: Jun 2, 2006 after 15 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 K963924 (1996). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990506: Mabis NB-02 Ultrasonic Nebulizer, Mabis Healthcare, Inc. (1999) Summary page 1.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.

## Most influential descendants
- K092918: Pari Vios (2010), 2 descendants of its own
- K191270: Proneb Max (2020), 0 descendants of its own
- K131881: Ombra Table Top Compressor (2013), 0 descendants of its own
- K092560: Pari Sinus (2010), 0 descendants of its own
- K082541: Healthline Medicator / Redineb Aerosol Drug Delivery System (2008), 0 descendants of its own

## Indications for use
The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.

Source page: https://510kreport.com/device/K061381
Methodology: https://510kreport.com/methodology