# K062158: LC Sprint Star

- Pathway: 510(k) (Traditional)
- Applicant: Pari Innovative Manufacturers, Inc.
- Decided: Aug 28, 2006 after 31 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 K963924 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060399: LC Sprint Nebulizer, Pari Innovative Manufacturers, Inc. (2006) Summary page 1.
- K963924: LC Star Reusable Nebulizer 22F50 and LC Star Disposable Nebulizer 22F70, Pari Holding Co. (1996) Summary page 1.
- (no number) Vixone Nebulizer: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K062158
Methodology: https://510kreport.com/methodology