Cleared Special

FloTrac sensors (K242909) - FDA 510(k) Clearance

Also marketed or referenced as:
FloTrac Jr sensors Acumen IQ sensors VolumeView sensors

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K242909 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
178d
Days
Class 2
Risk

K242909 is an FDA 510(k) clearance for the FloTrac sensors. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on March 21, 2025 after a review of 178 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Edwards Lifesciences, LLC devices

Submission Details

510(k) Number K242909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 125d · This submission: 178d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRS Transducer, Blood-pressure, Extravascular

All 147
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K242909.
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
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K904777 · Baxter Healthcare Corp · Jan 1991
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296 · Baxter Healthcare Corp · Jan 1989
DISPOSABLE FLUSH DEVICE
K860681 · Hewlett-Packard Co. · Jun 1986
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · Hewlett-Packard Co. · Jun 1985