Split Septum Injection Sites

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K041042 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Fresenius Medical Care North America →

• What is the primary purpose of the Split Septum Injection Sites?

  These components are designed specifically for use during hemodialysis procedures. They serve as an injection site plug that integrates into Fresenius Hemodialysis Blood Tubing Sets to allow for fluid access.

• Which types of needles are compatible with this injection site?

  The device features a tapered split design that accommodates either a 21 gauge metal needle or plastic needles with a 19 1/2 priming volume, ensuring versatility for standard hemodialysis clinical practices.

• What is the regulatory status of this device?

  The Split Septum Injection Sites have received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.