# K240706: PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)

- Pathway: 510(k) (Traditional)
- Applicant: Ganshorn Medizin Electronic GmbH
- Decided: Dec 9, 2024 after 270 days
- Product code: JEH (Plethysmograph, Volume)
- Device class: 2
- Regulation: 21 CFR 868.1760
- 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 K072061 (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)
- K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body, Viasys Healthcare GmbH (2008) Summary page 5.

## Indications for use
The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician. The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.

Source page: https://510kreport.com/device/K240706
Methodology: https://510kreport.com/methodology