Cleared Traditional

K240706 - PowerCube+ Series (PowerCube Body+)

Also marketed or referenced as:
PowerCube+ Series (PowerCube Diffusion+) PowerCube+ Series (PowerCube Body+ / Diffusion+)

K240706 is an FDA 510(k) clearance for PowerCube+ Series (PowerCube Body+), manufactured by Ganshorn Medizin Electronic GmbH. The device is a Class 2 Anesthesiology device with product code JEH cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K240706 · Ganshorn Medizin Electronic GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
270d
Days
Class 2
Risk

K240706 is an FDA 510(k) clearance for the PowerCube+ Series (PowerCube Body+). Classified as Plethysmograph, Volume (product code JEH), Class II - Special Controls.

Submitted by Ganshorn Medizin Electronic GmbH (Niederlauer, DE). The FDA issued a Cleared decision on December 9, 2024 after a review of 270 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1760 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ganshorn Medizin Electronic GmbH devices

FDA 510(k) Submission Details - K240706

510(k) Number K240706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2024
Decision Date December 09, 2024
Days to Decision 270 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 140d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEH Device Classification - Class 2, Special Controls

Product Code JEH Plethysmograph, Volume
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.