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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 / June 2026 / K253110

510(k) cleared

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

Sol-Millennium Medical, Inc. · Jun 18, 2026 · K253110

FDA cleared the Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe from Sol-Millennium Medical, Inc. on Jun 18, 2026 under K253110, a traditional 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 24, 2025. The decision came 267 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 Sol-Millennium Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253110?

K253110 is the FDA 510(k) for Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe, submitted by Sol-Millennium Medical, Inc.. FDA's decision date was Jun 18, 2026, under product code FMF (Syringe, Piston).

Who makes the Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe?

Sol-Millennium Medical, Inc., based in Chicago, IL, is the applicant of record for K253110.

How long did the K253110 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Jun 18, 2026, 267 days later.

← All decisions in June 2026