# K062689: Sidestream Plus

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Ltd.
- Decided: Feb 16, 2007 after 158 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 K935540 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935540: Pari-Master Modification, Pari Holding Co. (1995) Summary page 2.

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

Source page: https://510kreport.com/device/K062689
Methodology: https://510kreport.com/methodology