# K161534: EasyOne Pro Respiratory Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Ndd Medizintechnik AG
- Decided: Feb 22, 2017 after 264 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942211 (1994). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091428: Easyone Pro Respiratory Analysis System, Ndd Medizitechnik AG (2010) Summary page 4.
- K120635: Easyone Pro Respiratory Testing Device, Ndd Medizitechnik AG (2012) Summary page 4.

## Most influential descendants
- K221030: Model 9100 PFT/DICO (2022), 1 descendant of its own
- K223818: Model 9160 VitaloQUB (2023), 0 descendants of its own

## Recalls of this device
- Aug 15, 2017 · Class II · Z-0596-2020: The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shi
- Aug 15, 2017 · Class II · Z-0597-2020: The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shi

## Indications for use
EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals. EasyOne Pro/LAB can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements. EasyOne Pro/LAB is used to conduct lung function measurements on adults and children starting at age 4, except measurements of diffusing capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.

Source page: https://510kreport.com/device/K161534
Methodology: https://510kreport.com/methodology