510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000451Substantially Equivalent

Fresenius Combillines Single Needle Blood Tubing Set, Catalog #03-2290

Fresenius Medical Care Renal Therapies Group, LLC, Lexington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000451 is the FDA 510(k) clearance record for FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290, a class II device, cleared for Fresenius Medical Care North America on under FDA product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve). FDA records list 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC, from to . As of , FDA records show no recalls naming K000451.

Clearance record

Decision date
Received
(88 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
Fresenius Medical Care North America 95 Hayden Ave., Lexington MA
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 November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FJK, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260