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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 / K251286

510(k) cleared

Affirm 400

Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jan 21, 2026 · K251286

FDA cleared the Affirm 400 from Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) on Jan 21, 2026 under K251286, a traditional 510(k). The device falls under product code QFX, Diagnostic Neurosurgical Microscope Filter, regulated at 21 CFR 882.4950 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 25, 2025. The decision came 271 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 Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251286?

K251286 is the FDA 510(k) for Affirm 400, submitted by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). FDA's decision date was Jan 21, 2026, under product code QFX (Diagnostic Neurosurgical Microscope Filter).

Who makes the Affirm 400?

Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), based in Goleta, CA, is the applicant of record for K251286.

How long did the K251286 review take?

FDA received the submission on Apr 25, 2025 and issued its decision on Jan 21, 2026, 271 days later.

← All decisions in January 2026