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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K253412

510(k) cleared

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

Outset Medical, Inc. · Jan 26, 2026 · K253412

FDA cleared the Tablo Hemodialysis System (PN-0008000, PN-0006000U) from Outset Medical, Inc. on Jan 26, 2026 under K253412, a traditional 510(k). The device falls under product code KDI, Dialyzer, High Permeability With Or Without Sealed Dialysate System, regulated at 21 CFR 876.5860 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Sep 30, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Outset Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253412?

K253412 is the FDA 510(k) for Tablo Hemodialysis System (PN-0008000, PN-0006000U), submitted by Outset Medical, Inc.. FDA's decision date was Jan 26, 2026, under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System).

Who makes the Tablo Hemodialysis System (PN-0008000, PN-0006000U)?

Outset Medical, Inc., based in San Jose, CA, is the applicant of record for K253412.

How long did the K253412 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jan 26, 2026, 118 days later.

← All decisions in January 2026