510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822820Substantially Equivalent

Gas-Flow Meter Gfl 10

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

K822820 is the FDA 510(k) clearance record for GAS-FLOW METER GFL 10, a class II device, cleared for Gambro, Inc. on under FDA product code DTX (Gas Control Unit, Cardiopulmonary Bypass). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K822820.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DTX Gas Control Unit, Cardiopulmonary Bypass
Regulation
21 CFR 870.4300
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 DTX

Trailing 12 months

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

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