Cleared Traditional

K242451 - HemoSphere Alta Advanced Monitoring Pla...

Also marketed or referenced as:
HemoSphere Alta- monitor pressure cable (HEMAPSC200) Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)

K242451 is an FDA 510(k) clearance for HemoSphere Alta Advanced Monitoring Pla..., manufactured by Edwards Lifesciences. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K242451 · Edwards Lifesciences · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
115d
Days
Class 2
Risk

K242451 is an FDA 510(k) clearance for the HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1). Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Edwards Lifesciences (Irvine, US). The FDA issued a Cleared decision on December 9, 2024 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Edwards Lifesciences devices

FDA 510(k) Submission Details - K242451

510(k) Number K242451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2024
Decision Date December 09, 2024
Days to Decision 115 days
Submission Type Traditional
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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 57
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K242451.
Swan-Ganz Pacing Probe and Catheters
K233983 · Edwards Lifesciences · Jun 2024
Swan-Ganz catheter
K233824 · Edwards Lifesciences, LLC · Jun 2024
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
K231248 · Edwards Lifesciencess, LLC · Sep 2023
Swang-Ganz IQ pulmonary artery catheter
K222117 · Edwards Lifesiences, LLC · Dec 2022
Swan-Ganz Catheters
K193466 · Edwards Lifesciences, LLC · Feb 2020
Swan Ganz Catheters
K160084 · Edwards Lifesciences, LLC · May 2016