Cleared Special

HemoSphere Stream Module

K253034 · Edwards Lifesciences · Cardiovascular
Oct 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K253034 is an FDA 510(k) clearance for the HemoSphere Stream Module, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on October 21, 2025, 29 days after receiving the submission on September 22, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K253034 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2025
Decision Date October 21, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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