510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861586Substantially Equivalent

Lopez Valve

Abbott Medical, Huntington Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861586 is the FDA 510(k) clearance record for LOPEZ VALVE, a class II device, cleared for Icu Medical, Inc. on under FDA product code MJF (Check Valve, Retrograde Flow (In-Line)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K861586.

Clearance record

Decision date
Received
(111 days to decision)
Product code
MJF Check Valve, Retrograde Flow (In-Line)
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical, Inc. 5200 Warner Ave., Suite 108, Huntington Beach CA
Third party review
No

Clearances, product code MJF

Trailing 12 months

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

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