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FDA 510(k)

AK 98 Dialysis Machine (955607)

K-Number: K250508 · 2025-08-01

ApplicantVantive US Healthcare, LLC
Decision Date2025-08-01
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AK 98 Dialysis Machine (955607) is the device name listed in this FDA 510(k) record. The listed applicant is Vantive US Healthcare, LLC. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250508. 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 AK 98 Dialysis Machine (955607)?

AK 98 Dialysis Machine (955607) is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Vantive US Healthcare, LLC. The 510(k) number is K250508.

When did AK 98 Dialysis Machine (955607) receive FDA 510(k) clearance?

AK 98 Dialysis Machine (955607) received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250508.

Who is the listed applicant for AK 98 Dialysis Machine (955607)?

The FDA 510(k) record lists Vantive US Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AK 98 Dialysis Machine (955607)?

The FDA product code for AK 98 Dialysis Machine (955607) is KDI.

Other records listing Vantive US Healthcare, LLC 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.

PMA P830063Separator for therapeutic purposes, membrane automated blood cell/plasma

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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