# K160116: SpiroScout

- Pathway: 510(k) (Traditional)
- Applicant: Ganshorn Medizin Electronic GmbH
- Decided: Oct 7, 2016 after 262 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- 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 K944762 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993921: NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001, Ndd Medical Technologies (2000) Summary page 4.

## Indications for use
The Ganshorn SpiroScout is intended for prescription use only to conduct simple diagnostic spirometry testing of adults and pediatric patients over 5 years old, in general practice and specialty physician, industrial and hospital settings.

Source page: https://510kreport.com/device/K160116
Methodology: https://510kreport.com/methodology