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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 / November 2025 / K251821

510(k) cleared

ARC-EX System

Onward Medical, Inc. · Nov 14, 2025 · K251821

FDA cleared the ARC-EX System from Onward Medical, Inc. on Nov 14, 2025 under K251821, a traditional 510(k). The device falls under product code SDO, Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation, regulated at 21 CFR 890.5851 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jun 13, 2025. The decision came 154 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 Onward Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251821?

K251821 is the FDA 510(k) for ARC-EX System, submitted by Onward Medical, Inc.. FDA's decision date was Nov 14, 2025, under product code SDO (Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation).

Who makes the ARC-EX System?

Onward Medical, Inc., based in Boston, MA, is the applicant of record for K251821.

How long did the K251821 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Nov 14, 2025, 154 days later.

← All decisions in November 2025