510(k) K250912

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

November 19, 2025

Date Received

March 27, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Deformability Cytometry For Sepsis Risk Assessment

Device Class

Class II

Regulation Number

866.3215

Review Panel

MI

Submission Type

A semi-quantitative assay that measures cellular deformability and other physical properties of leukocytes in whole blood samples to aid the early detection of sepsis