Cleared Traditional

HemoSphere Nano Monitor (HSNANO1)

K253186 · Edwards Lifesciences, LLC · Cardiovascular
Feb 2026
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K253186 is an FDA 510(k) clearance for the HemoSphere Nano Monitor (HSNANO1), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on February 24, 2026, 151 days after receiving the submission on September 26, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K253186 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2025
Decision Date February 24, 2026
Days to Decision 151 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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