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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 / May 2026 / K250814

510(k) cleared

Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB

Zeus Scientific · May 8, 2026 · K250814

FDA cleared the Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB from Zeus Scientific on May 8, 2026 under K250814, a traditional 510(k). The device falls under product code OBE, Anti-Ss-A 52 Autoantibodies, regulated at 21 CFR 866.5100 as a Class 2 device. The review panel was Immunology.

FDA logged the submission as received on Mar 17, 2025. The decision came 417 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zeus Scientific has 2 other decisions in the tracker over the last 12 months: K250666 (Alegria Flash CTD Screen), K250408 (Alegria Flash ENA Screen).

Questions & Answers

What did FDA clear under K250814?

K250814 is the FDA 510(k) for Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB, submitted by Zeus Scientific. FDA's decision date was May 8, 2026, under product code OBE (Anti-Ss-A 52 Autoantibodies).

Who makes the Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB?

Zeus Scientific, based in Branchburg, NJ, is the applicant of record for K250814.

How long did the K250814 review take?

FDA received the submission on Mar 17, 2025 and issued its decision on May 8, 2026, 417 days later.

← All decisions in May 2026

Sources