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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 a medical device manufactured by Vantive US Healthcare, LLC. It received FDA 510(k) clearance on 2025-08-01 under approval 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. It is manufactured by Vantive US Healthcare, LLC. The 510(k) number is K250508.

When was AK 98 Dialysis Machine (955607) approved by the FDA?

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

What company makes AK 98 Dialysis Machine (955607)?

AK 98 Dialysis Machine (955607) is manufactured by Vantive US Healthcare, LLC.

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

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

Related Clinical Trials

NCT07604662 Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial NOT_YET_RECRUITING NCT06832696 Assessment of a Wearable Ultrafiltration Device NOT_YET_RECRUITING

Other Devices by Vantive US Healthcare, LLC

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

Related Devices (Code: 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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