Cleared Traditional

Tablo® Hemodialysis System (K232776) - FDA 510(k) Clearance

Also marketed or referenced as:
TabloCart™ with Prefiltration Drawer

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232776 · Outset Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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May 2024
Decision
235d
Days
Class 2
Risk

K232776 is an FDA 510(k) clearance for the Tablo® Hemodialysis System. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Outset Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on May 3, 2024 after a review of 235 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Outset Medical, Inc. devices

Submission Details

510(k) Number K232776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2023
Decision Date May 03, 2024
Days to Decision 235 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 130d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 77
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K232776.
Moda-flx Hemodialysis System and Cartridge
K233798 · Diality, Inc. · Aug 2024
HemoCare Hemodialysis System
K233557 · Deka Research and Development · Jul 2024
multiFlux 1000 (F00012408)
K240394 · Fresenius Medical Care Renal Therapies Group, LLC · May 2024
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
K232803 · Nxstage Medical, Inc. · Mar 2024
Purema® H Hemoconcentrator (EtO Sterilized)
K232171 · Tecnoideal America · Feb 2024
5008X Hemodialysis System
K231534 · Fresenius Medical Care · Feb 2024