510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894255Substantially Equivalent

St.jude Medical Pulse 2100 Centrifugal Pump

Abbott Medical, Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894255 is the FDA 510(k) clearance record for ST.JUDE MEDICAL PULSE 2100 CENTRIFUGAL PUMP, a class II device, cleared for St. Jude Medical, Inc. on under FDA product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K894255.

Clearance record

Decision date
Received
(98 days to decision)
Product code
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation
21 CFR 870.4360
Device class
Class II
Review panel
Cardiovascular
Applicant
St. Jude Medical, Inc. 825 N 300 W, Salt Lake City UT
Third party review
No

Clearances, product code KFM

Trailing 12 months

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

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