510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061143Substantially Equivalent

Robertsite Stopcock

Halkey-Roberts Corporation, St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061143 is the FDA 510(k) clearance record for ROBERTSITE STOPCOCK, a class II device, cleared for Halkey-Roberts Corp. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 2 510(k) clearances for Halkey-Roberts Corp., from to . As of , FDA records show no recalls naming K061143.

Clearance record

Decision date
Received
(15 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Halkey-Roberts Corp. 11600 M.L. King Blvd.,North, St. Petersburg FL
510(k) summary
Summary PDF
Third party review
Yes

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