# K170853: InnoSpire Go

- Pathway: 510(k) (Traditional)
- Applicant: Respironics Respiratory Drug Delivery (Uk), Ltd.
- Decided: Nov 2, 2017 after 225 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 K081650 (2008). 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)
- K081650: Aeroneb GO Nebulizer, Aerogen (Ireland), Ltd. (2008) Summary page 4.

## Indications for use
The InnoSpire Go is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (2 years and older), defined by the prescribed medication, and adults patients in the home environment or in a hospital/clinic setting.

Source page: https://510kreport.com/device/K170853
Methodology: https://510kreport.com/methodology