510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171346Substantially Equivalent

Sapphire Sets

Abbott Medical, Lake Forest IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171346 is the FDA 510(k) clearance record for Sapphire Sets, a class II device, cleared for Icu Medical on under FDA product code MRZ (Accessories, Pump, Infusion). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 9 recalls naming K171346.

Clearance record

Decision date
Received
(109 days to decision)
Product code
MRZ Accessories, Pump, Infusion
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Icu Medical 600 N. Field Dr., Lake Forest IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRZ

Trailing 12 months

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

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