K223509 is an FDA 510(k) clearance for the Compremium Compartment Compressibility Monitoring System (CPM#1). Classified as Monitor, Pressure, Intracompartmental (product code LXC).
Submitted by Compremium AG (Muri, CH). The FDA issued a Cleared decision on April 14, 2023 after a review of 143 days - within the typical 510(k) review window.
This device falls under the Orthopedic FDA review panel. 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.
View all Compremium AG devices
NCT05483946
Completed
Interventional
Industry-sponsored
SWISS_CLEARANCE - Compartment Compressibility Monitoring Using CPM#1
Validation of CPM#1 Compressibility Ratio in a Clinical Study of Healthy Volunteers: Evaluation of the Test-retest Repeatability
| Condition studied |
Compartment Syndromes |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Beat Lehmann |
| Sponsor |
Compremium AG
(industry)
|
Started 2022-11-01
→
Primary completion 2022-11-01
Primary outcome
Inter-operator reproducibility with 3 raters
Secondary outcome
Intra-operator reproducibility
Study completed - no results published.
This trial concluded in 2022 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
Individual participant data will not be shared.
View full study on ClinicalTrials.gov