510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K082836Substantially Equivalent

ICU Medical Universal Single-Use Spikes

Abbott Medical, Salt Lake City UT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082836 is the FDA 510(k) clearance record for ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES, a class II device, cleared for Icu Medical, Inc. on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K082836.

Clearance record

Decision date
Received
(152 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical, Inc. 4455 Atherton Dr., Salt Lake City UT
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMG, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260