510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822071Substantially Equivalent

Pump Modules Pmo Lo-110-Pmd 10-210

Gambro, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822071 is the FDA 510(k) clearance record for PUMP MODULES PMO LO-110-PMD 10-210, a class II device, cleared for Gambro, Inc. on under FDA product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K822071.

Clearance record

Decision date
Received
(41 days to decision)
Product code
DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Regulation
21 CFR 870.4370
Device class
Class II
Review panel
Cardiovascular
Applicant
Gambro, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DWB

Trailing 12 months

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

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