Cleared Traditional

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform (K211465) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211465 · Edwards Lfesciences · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
58d
Days
Class 2
Risk

K211465 is an FDA 510(k) clearance for the HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitorin.... Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Edwards Lfesciences (Irvine, US). The FDA issued a Cleared decision on July 8, 2021 after a review of 58 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Edwards Lfesciences devices

Submission Details

510(k) Number K211465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2021
Decision Date July 08, 2021
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K211465.
AcQMap High Resolution Imaging and Mapping System
K212345 · Acutus Medical, Inc. · Aug 2021
iMap 3D Mapping & Navigation System (iMap System)
K201094 · Cardionxt, Inc. · Aug 2021
AcQMap High Resolution Imaging and Mapping System
K210680 · Acutus Medical, Inc. · Aug 2021
iLab Polaris Multi-Modality Guidance System
K210889 · Boston Scientific Corporation · Jun 2021
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
K203687 · Edwards Lifesciences, LLC · May 2021
Zio ECG Utilization Software (ZEUS) System
K202527 · iRhythm Technologies, Inc. · May 2021