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FDA 510(k)

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)

K-Number: K242155 · 2025-05-15

ApplicantNIKKISO CO., LTD.
Decision Date2025-05-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) is the device name listed in this FDA 510(k) record. The listed applicant is NIKKISO CO., LTD.. It received FDA 510(k) clearance on 2025-05-15 under 510(k) number K242155. 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 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)?

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) is a medical device that received FDA 510(k) clearance on 2025-05-15. The listed applicant is NIKKISO CO., LTD.. The 510(k) number is K242155.

When did DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) receive FDA 510(k) clearance?

DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) received FDA 510(k) clearance on 2025-05-15, under 510(k) number K242155.

Who is the listed applicant for DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)?

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

What is the FDA product code for DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)?

The FDA product code for DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) is KDI.

Other records listing NIKKISO CO., LTD. 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.

K242479BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PUK242176BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)K231589Blood Tubing Lines for Hemodialysis AV06C-EK230514Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 SeriesK152938DBB-06 Hemodialysis Delivery System

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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