510(k) · Cleared
ClearedPowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ganshorn Medizin Electronic GmbH · JEH Plethysmograph, Volume
Cleared on Dec 9, 2024 as substantially equivalent to K072061 (Viasys Healthcare GmbH, 2008) after a 270-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Dec 9, 2024
- Review
- 270 days
- Class
- Class II
- Product code
- JEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072061 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK072061 Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodyViasys Healthcare GmbH · 2008
- This deviceK240706 PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube…Ganshorn Medizin Electronic GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body | Viasys Healthcare GmbH | 2008 | — |
| 0 (this device) | K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+)… | Ganshorn Medizin Electronic GmbH | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JEH device
- #1 K223818 Model 9160 VitaloQUBscore 6.3 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072061 | Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT BodySummary page 5…868.1760, 868.1840 Product Codes: JEH, BZG Device Class: 2 Legally Marketed Predicate Device Predicate #: K072061 Trade Name: MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY Common… | 2008 |
| † | K160116 | SpiroScout | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K072061.
How does its category compare?
All JEH devicesJEH Plethysmograph, Volume: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JEH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JEH
Too few JEH 510(k)s in any year since 2007 to give a median.
Recalls per year · JEH
No recall names JEH since 2007.
Adverse event reports per year · JEH
1in 2024
MAUDE reports naming product code JEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240706: PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240706
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026