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FDA 510(k)

HDF Assist Mudule, HDF Infusion Set and Substitution Filter

K-Number: K210575 · 2022-05-13

ApplicantNephros
Decision Date2022-05-13
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HDF Assist Mudule, HDF Infusion Set and Substitution Filter is the device name listed in this FDA 510(k) record. The listed applicant is Nephros. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K210575. 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 HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

HDF Assist Mudule, HDF Infusion Set and Substitution Filter is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Nephros. The 510(k) number is K210575.

When did HDF Assist Mudule, HDF Infusion Set and Substitution Filter receive FDA 510(k) clearance?

HDF Assist Mudule, HDF Infusion Set and Substitution Filter received FDA 510(k) clearance on 2022-05-13, under 510(k) number K210575.

Who is the listed applicant for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

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

What is the FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

The FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter is KDI.

Other records listing Nephros 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.

K161304EndoPur FilterK161467HydraGuard 10 UltraFilterK153084Nephros S100

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

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

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