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FDA 510(k)

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)

K-Number: K242053 · 2025-03-21

ApplicantFresenius Medical Care Renal Therapies Group, LLC
Decision Date2025-03-21
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-03-21 under approval number K242053. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)?

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K242053.

When was FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) approved by the FDA?

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) received FDA 510(k) clearance on 2025-03-21, under approval number K242053.

What company makes FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)?

FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)?

The FDA product code for FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) is KDI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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