# K991725: Sidestream Nebulizer

- Pathway: 510(k) (Traditional)
- Applicant: Inspired Medical Products, Ltd.
- Decided: Jul 30, 1999 after 71 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 K914152 (1992). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924123: Sidestream Disposable, Medic-Aid, Ltd. (1992) Summary page 1.
- K914152: Sidestream Drug Nebulizer, Medic-Aid, Ltd. (1992) Summary page 1.

## Most influential descendants
- K072163: Happyneb II, Happyneb Iii, Speedy, Nebby Plus and Myneb, Model 5 (2008), 0 descendants of its own
- K062484: Flaem Nuova RF6 Basic and RF6 Plus Nebulizers (2007), 0 descendants of its own

## Indications for use
A hand-held nebulizer to aerosolize commonly prescribed liquid drugs (except pentamadine) for inhalation by patients in the Home, Hospital and Nursing Home settings - anywhere aerosolized drug delivery is utilized.

Source page: https://510kreport.com/device/K991725
Methodology: https://510kreport.com/methodology