510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983559Substantially Equivalent

Blood Tubing Accessory with Clave Connector

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

K983559 is the FDA 510(k) clearance record for BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR, a class II device, cleared for Icu Medical, Inc. on under FDA product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 54 recalls naming K983559.

Clearance record

Decision date
Received
(72 days to decision)
Product code
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Icu Medical, Inc. 951 Calle Amanecer, San Clemente CA
510(k) summary
Summary
Third party review
No

Clearances, product code FJK

Trailing 12 months
2 clearances under product code FJK in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FJK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260