510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190539Substantially Equivalent

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

Monumedical, LLC, Roseville CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190539 is the FDA 510(k) clearance record for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile, a class II device, cleared for Monumedical, LLC on under FDA product code FMG (Stopcock, I.V. Set). FDA records list one 510(k) clearance for Monumedical, LLC. As of , FDA records show no recalls naming K190539.

Clearance record

Decision date
Received
(232 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Monumedical, LLC 3017 Douglas Blvd., Suite 300, Roseville CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMG

Trailing 12 months

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

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