510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011838Substantially Equivalent

Centrifugal Pump

Stockert Instrumente GmbH, North Attleboro MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011838 is the FDA 510(k) clearance record for CENTRIFUGAL PUMP, a class II device, cleared for Stockert Instrumente GmbH on under FDA product code DWA (Control, Pump Speed, Cardiopulmonary Bypass). FDA records list 9 510(k) clearances for Stockert Instrumente GmbH, from to . As of , FDA records show 4 recalls naming K011838.

Clearance record

Decision date
Received
(238 days to decision)
Product code
DWA Control, Pump Speed, Cardiopulmonary Bypass
Regulation
21 CFR 870.4380
Device class
Class II
Review panel
Cardiovascular
Applicant
Stockert Instrumente GmbH 49 Plain St., North Attleboro MA
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