Cleared Traditional

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)

K252533 · Edwards Lifesciences · Cardiovascular
Dec 2025
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K252533 is an FDA 510(k) clearance for the HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on December 18, 2025, 128 days after receiving the submission on August 12, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K252533 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2025
Decision Date December 18, 2025
Days to Decision 128 days
Submission Type Traditional
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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