510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201446Substantially Equivalent

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

Edwards Lifesiences, LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201446 is the FDA 510(k) clearance record for HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module, a class II device, cleared for Edwards Lifesiences, LLC on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 2 510(k) clearances for Edwards Lifesiences, LLC, from to . As of , FDA records show one recall naming K201446.

Clearance record

Decision date
Received
(122 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesiences, LLC One Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQK

Trailing 12 months
25 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20260