Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Moda-flx Hemodialysis System and Cartridge

K-Number: K233798 · 2024-08-02

ApplicantDiality, Inc.
Decision Date2024-08-02
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Moda-flx Hemodialysis System and Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Diality, Inc.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K233798. 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 Moda-flx Hemodialysis System and Cartridge?

Moda-flx Hemodialysis System and Cartridge is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Diality, Inc.. The 510(k) number is K233798.

When did Moda-flx Hemodialysis System and Cartridge receive FDA 510(k) clearance?

Moda-flx Hemodialysis System and Cartridge received FDA 510(k) clearance on 2024-08-02, under 510(k) number K233798.

Who is the listed applicant for Moda-flx Hemodialysis System and Cartridge?

The FDA 510(k) record lists Diality, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Moda-flx Hemodialysis System and Cartridge?

The FDA product code for Moda-flx Hemodialysis System and Cartridge is KDI.

Related Clinical Trials

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.

NCT06613568Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by ParticipantsRECRUITING

Other records listing Diality, Inc. 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.

K243607Moda-flx Hemodialysis System™ Cartridge (102121-001 )

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.

↑