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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 / April 2026 / K240974

510(k) cleared

SPRINT PNS System

Spr Therapeutics, Inc. · Apr 14, 2026 · K240974

FDA cleared the SPRINT PNS System from Spr Therapeutics, Inc. on Apr 14, 2026 under K240974, a traditional 510(k). The device falls under product code SCN, Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief, regulated at 21 CFR 882.5870 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 10, 2024. The decision came 734 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 Spr Therapeutics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K240974?

K240974 is the FDA 510(k) for SPRINT PNS System, submitted by Spr Therapeutics, Inc.. FDA's decision date was Apr 14, 2026, under product code SCN (Temporarily Implanted Peripheral Nerve Stimulation System For Sustained Pain Relief).

Who makes the SPRINT PNS System?

Spr Therapeutics, Inc., based in Cleveland, OH, is the applicant of record for K240974.

How long did the K240974 review take?

FDA received the submission on Apr 10, 2024 and issued its decision on Apr 14, 2026, 734 days later.

← All decisions in April 2026