510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253034Substantially Equivalent

HemoSphere Stream Module

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

K253034 is the FDA 510(k) clearance record for HemoSphere Stream Module, a class II device, cleared for Edwards Lifesciences on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 165 510(k) clearances for Edwards Lifesciences, from to . As of , FDA records show no recalls naming K253034.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences 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