510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831404Substantially Equivalent

Blood Monitor Bmm 10-4

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

K831404 is the FDA 510(k) clearance record for BLOOD MONITOR BMM 10-4, a class II device, cleared for Gambro, Inc. on under FDA product code LLB (System, Blood, Extracorporeal And Accessories). FDA records list 87 510(k) clearances for Gambro, Inc., from to . As of , FDA records show no recalls naming K831404.

Clearance record

Decision date
Received
(359 days to decision)
Product code
LLB System, Blood, Extracorporeal And Accessories
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code LLB

Trailing 12 months

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

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