Fresenius Priming Set with Needles Access Port, Model 04-9002-9

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

510(k) Number

K010268 ↗

FDA Product Code

KOC

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

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 Fresenius Priming Set with Needles Access Port, Model 04-9002-9, and how does it integrate with hemodialysis procedures?

  This device is designed specifically to prime hemodialysis circuits by ensuring fluid flow and providing a sterile connection point for vascular access. The included needles and access port allow it to interface directly with the patient’s vascular access during dialysis, facilitating the setup of the blood circuit before the procedure begins.

• Is the Fresenius Priming Set with Needles Access Port intended for single-use or can it be reused?

  The device is explicitly labeled as a single-use, sterile priming set. This classification ensures patient safety by preventing contamination and cross-infection between uses, which is critical in hemodialysis settings where sterility is paramount.

• What regulatory pathway was followed for the FDA clearance of this priming set, and what does that mean for its use in clinical settings?

  The device received FDA clearance through a 510(k) submission (K010268), classified under Traditional review and determined to be Substantially Equivalent (SESE) to a predicate device. This means it has undergone rigorous evaluation to confirm its safety and effectiveness for its intended use as an accessory in hemodialysis circuits, ensuring compliance with FDA standards before clinical deployment.

• How is the device supplied, and what components does it include to ensure compatibility with hemodialysis machines?

  The priming set is supplied as a complete, sterile package containing needles and an access port, all designed to work seamlessly with hemodialysis machines and circuits. The access port provides a secure connection point for vascular access, while the needles facilitate fluid flow during priming, ensuring the circuit is ready for patient use without additional setup complications.