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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 / K251849

510(k) cleared

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)

Staclear, Inc. · Nov 21, 2025 · K251849

FDA cleared the StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) from Staclear, Inc. on Nov 21, 2025 under K251849, a traditional 510(k). The device falls under product code QLY, Ophthalmic Syringe, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 16, 2025. The decision came 158 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 Staclear, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251849?

K251849 is the FDA 510(k) for StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL), submitted by Staclear, Inc.. FDA's decision date was Nov 21, 2025, under product code QLY (Ophthalmic Syringe).

Who makes the StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

Staclear, Inc., based in Raleigh, NC, is the applicant of record for K251849.

How long did the K251849 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Nov 21, 2025, 158 days later.

← All decisions in November 2025