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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 / March 2026 / K251777

510(k) cleared

MESI mTABLET SPIRO

Mesi D.O.O. · Mar 2, 2026 · K251777

FDA cleared the MESI mTABLET SPIRO from Mesi D.O.O. on Mar 2, 2026 under K251777, a traditional 510(k). The device falls under product code BZG, Spirometer, Diagnostic, regulated at 21 CFR 868.1840 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jun 10, 2025. The decision came 265 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 Mesi D.O.O. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251777?

K251777 is the FDA 510(k) for MESI mTABLET SPIRO, submitted by Mesi D.O.O.. FDA's decision date was Mar 2, 2026, under product code BZG (Spirometer, Diagnostic).

Who makes the MESI mTABLET SPIRO?

Mesi D.O.O., based in Ljubljana, is the applicant of record for K251777.

How long did the K251777 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Mar 2, 2026, 265 days later.

← All decisions in March 2026