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FDA 510(k)

HemoCare Hemodialysis System

K-Number: K233557 · 2024-07-12

ApplicantDeka Research and Development
Decision Date2024-07-12
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HemoCare Hemodialysis System is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2024-07-12 under 510(k) number K233557. 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 HemoCare Hemodialysis System?

HemoCare Hemodialysis System is a medical device that received FDA 510(k) clearance on 2024-07-12. The listed applicant is Deka Research and Development. The 510(k) number is K233557.

When did HemoCare Hemodialysis System receive FDA 510(k) clearance?

HemoCare Hemodialysis System received FDA 510(k) clearance on 2024-07-12, under 510(k) number K233557.

Who is the listed applicant for HemoCare Hemodialysis System?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoCare Hemodialysis System?

The FDA product code for HemoCare Hemodialysis System is KDI.

Related Clinical Trials

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NCT06853990Innovative Automated Insulin Delivery System for Type 2 DiabetesCOMPLETED

Other records listing Deka Research and Development as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261672twiist Automated Insulin Delivery (AID) SystemK261530iiSure Infusion SetK243841Sparta Infusion Set for InsulinK241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionK242693DEKA Infusion System, DEKA Administration SetK240920HemoCare Bicarbonate Concentrate Set (BCS)

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Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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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