# K161536: EasyOne Air Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Ndd Medizintechnik AG
- Decided: Jan 5, 2017 after 216 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K230178: EasyOne Sky Spirometer (2023), 0 descendants of its own

## Indications for use
The EasyOne Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinics, in pharmacies, and in clinical settings in occupational medicine.

Source page: https://510kreport.com/device/K161536
Methodology: https://510kreport.com/methodology