510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202125Substantially Equivalent

Century Perfusion System

Century HLM, LLC, Mesa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202125 is the FDA 510(k) clearance record for Century Perfusion System, a class II device, cleared for Century Hlm, LLC on under FDA product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass). FDA records list one 510(k) clearance for Century Hlm, LLC. As of , FDA records show no recalls naming K202125.

Clearance record

Decision date
Received
(219 days to decision)
Product code
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation
21 CFR 870.4220
Device class
Class II
Review panel
Cardiovascular
Applicant
Century Hlm, LLC 3110 N Oakland, Suite 101, Mesa AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTQ

Trailing 12 months

FDA records hold no clearances under product code DTQ in the trailing twelve months.

FDA records show no clearances under product code DTQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260