Cleared Traditional

Tablo® Hemodialysis System (K223248) - FDA 510(k) Clearance

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

K223248 · Outset Medical, Inc. · Gastroenterology & Urology device
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Jun 2023
Decision
243d
Days
Class 2
Risk

K223248 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 June 21, 2023 after a review of 243 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 K223248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2022
Decision Date June 21, 2023
Days to Decision 243 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
113d slower than avg
Panel avg: 130d · This submission: 243d
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 K223248.
Tablo® Hemodialysis System
K233335 · Outset Medical, Inc. · Dec 2023
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
K232467 · Baxter Healthcare Corporation · Sep 2023
VersiHD with GuideMe software
K230632 · Nxstage Medical, Inc. · Aug 2023
ClearumTM HS
K231406 · Bellco Srl · Jun 2023
FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000
K220721 · Fresenius Medical Care Renal Therapies Group, LLC · May 2023
multiFiltratePRO System
K220281 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2022