510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941921Substantially Equivalent

Bio-Medicus Bio-Console Models 540, 540A,b,c,d,e, & 550

Medtronic Bio-Medicus, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941921 is the FDA 510(k) clearance record for BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550, a class II device, cleared for Medtronic Bio-Medicus, Inc. on under FDA product code DWA (Control, Pump Speed, Cardiopulmonary Bypass). FDA records list 13 510(k) clearances for Medtronic Bio-Medicus, Inc., from to . As of , FDA records show one recall naming K941921.

Clearance record

Decision date
Received
(91 days to decision)
Product code
DWA Control, Pump Speed, Cardiopulmonary Bypass
Regulation
21 CFR 870.4380
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Bio-Medicus, Inc. 9600 W. 76th St., Eden Prairie MN
510(k) summary
Summary
Third party review
No

Clearances, product code DWA

Trailing 12 months

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

FDA records show no clearances under product code DWA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWA, 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