# K091428: Easyone Pro Respiratory Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Ndd Medizitechnik AG
- Decided: Jan 27, 2010 after 258 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- 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 K942211 (1994). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K942211: VMAX229 Series Pulmonary/Metabolic Systems, Sensor Medics Corp. (1994) Summary page 1.

## Most influential descendants
- K161534: EasyOne Pro Respiratory Analysis System (2017), 2 descendants of its own
- K221030: Model 9100 PFT/DICO (2022), 1 descendant of its own
- K223818: Model 9160 VitaloQUB (2023), 0 descendants of its own

## Indications for use
The ndd EasyOne Pro Respiratory Analysis System is designed for conducting lung function measurements in general or specialist practices or in hospitals. The EasyOne Pro Respiratory Analysis System can also be used outside of the laboratory when performing lung function screenings or measurements in occupational medicine. The EasyOne Pro Respiratory Analysis System is used to conduct slow and forced spirometry on adults and children starting at age 4. Measurement of Diffusing Capacity of the lung based on CO (DLCO) can be performed on adults and children starting at age 6.

Source page: https://510kreport.com/device/K091428
Methodology: https://510kreport.com/methodology