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# Koru Medical Prefilled Syringe Pump Cleared
- URL: https://www.fdaweb.com/koru-medical-prefilled-syringe-pump-cleared/
- Published: 2023-11-07T12:00:00.000Z
- Updated: 2026-09-14T14:15:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155744

FDA has cleared a Koru Medical Systems 510(k) for the Freedom60 Infusion System with Hizentra 50 mL prefilled syringes. “Prefilled syringes are proven to provide a significant improvement in ease of use for all patients, and in administering higher doses of immunoglobulin, including for PIDD \[primary immunodeficiency disorder\] and CIDP \[chronic inflammatory demyelinating polyradiculoneuropathy\] patients,” the company says. “When using prefilled syringes with the Freedom Infusion System, Koru Medical has demonstrated that patients can experience up to an 80% reduction in drug preparation tasks when compared to using vials,” it adds.