Cleared Traditional

K201446 - HemoSphere Advanced Monitoring Platform

K201446 is an FDA 510(k) clearance for HemoSphere Advanced Monitoring Platform, manufactured by Edwards Lifesiences, LLC. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K201446 · Edwards Lifesiences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
122d
Days
Class 2
Risk

K201446 is an FDA 510(k) clearance for the HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Edwards Lifesiences, LLC (Irvine, US). The FDA issued a Cleared decision on October 1, 2020 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 Lifesiences, LLC devices

FDA 510(k) Submission Details - K201446

510(k) Number K201446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2020
Decision Date October 01, 2020
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 268
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K201446.
Cordiana Dx16
K201060 · Cordiana Medical Informatics AG · Nov 2020
CoroFlow Cardiovascular System
K201881 · Coroventis Research AB · Nov 2020
KardiaAI
K201985 · AliveCor, Inc. · Nov 2020
VX1
K201298 · Volta Medical · Sep 2020
VIVO
K200313 · Catheter Precision, Inc. · Sep 2020
AVVIGO Guidance System
K201713 · Boston Scientific Corporation · Jul 2020