510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864094Substantially Equivalent

Gambro Fluid Control Monitor Fcm 10-1

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

K864094 is the FDA 510(k) clearance record for GAMBRO FLUID CONTROL MONITOR FCM 10-1, a class II device, cleared for Gambro, Inc. on under FDA product code FKP (System, Dialysate Delivery, Single Patient). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K864094.

Clearance record

Decision date
Received
(17 days to decision)
Product code
FKP System, Dialysate Delivery, Single Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro, Inc. 600 Knightsbridge Pkwy., Lincolnshire IL
Third party review
No

Clearances, product code FKP

Trailing 12 months

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

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