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FDA 510(k)

Tablo® Hemodialysis System

K-Number: K223248 · 2023-06-21

ApplicantOutset Medical, Inc.
Decision Date2023-06-21
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Tablo® Hemodialysis System is the device name listed in this FDA 510(k) record. The listed applicant is Outset Medical, Inc.. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K223248. 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?

Tablo® Hemodialysis System is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Outset Medical, Inc.. The 510(k) number is K223248.

When did Tablo® Hemodialysis System receive FDA 510(k) clearance?

Tablo® Hemodialysis System received FDA 510(k) clearance on 2023-06-21, under 510(k) number K223248.

Who is the listed applicant for Tablo® Hemodialysis System?

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

What is the FDA product code for Tablo® Hemodialysis System?

The FDA product code for Tablo® Hemodialysis System is KDI.

Other records listing Outset Medical, Inc. 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.

K253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerK233335Tablo® Hemodialysis SystemK211370Tablo Hemodialysis SystemK210782Tablo CartridgeK200741Tablo Hemodialysis System

View all 9 devices →

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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