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FDA 510(k)

Tablo Hemodialysis System (PN-0008000, PN-0006000U)

K-Number: K253412 · 2026-01-26

ApplicantOutset Medical, Inc.
Decision Date2026-01-26
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tablo Hemodialysis System (PN-0008000, PN-0006000U) is a medical device manufactured by Outset Medical, Inc.. It received FDA 510(k) clearance on 2026-01-26 under approval number K253412. 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 Tablo Hemodialysis System (PN-0008000, PN-0006000U)?

Tablo Hemodialysis System (PN-0008000, PN-0006000U) is a medical device that received FDA 510(k) clearance on 2026-01-26. It is manufactured by Outset Medical, Inc.. The 510(k) number is K253412.

When was Tablo Hemodialysis System (PN-0008000, PN-0006000U) approved by the FDA?

Tablo Hemodialysis System (PN-0008000, PN-0006000U) received FDA 510(k) clearance on 2026-01-26, under approval number K253412.

What company makes Tablo Hemodialysis System (PN-0008000, PN-0006000U)?

Tablo Hemodialysis System (PN-0008000, PN-0006000U) is manufactured by Outset Medical, Inc..

What is the FDA product code for Tablo Hemodialysis System (PN-0008000, PN-0006000U)?

The FDA product code for Tablo Hemodialysis System (PN-0008000, PN-0006000U) is KDI.

Related Clinical Trials

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Other Devices by Outset Medical, Inc.

K160881Tablo Console K190793Tablo Hemodialysis System, Tablo Cartridge K200741Tablo Hemodialysis System K210782Tablo Cartridge K211370Tablo Hemodialysis System K233335Tablo® Hemodialysis System

View all 9 devices →

Related Devices (Code: KDI)

K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl K160881Tablo ConsoleOutset Medical, Inc. K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD. K143482xevonta dialyzerB. Braun Avitum AG K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.

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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