Cleared Special

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

K242909 · Edwards Lifesciences, LLC · Cardiovascular
Mar 2025
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K242909 is an FDA 510(k) clearance for the FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors, a Transducer, Blood-pressure, Extravascular (Class II — Special Controls, product code DRS), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on March 21, 2025, 178 days after receiving the submission on September 24, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2850.

Submission Details

510(k) Number K242909 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2024
Decision Date March 21, 2025
Days to Decision 178 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRS — Transducer, Blood-pressure, Extravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2850

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