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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 / February 2026 / K251678

510(k) cleared

Swift Ray 1

Swift Medical, Inc. · Feb 24, 2026 · K251678

FDA cleared the Swift Ray 1 from Swift Medical, Inc. on Feb 24, 2026 under K251678, a traditional 510(k). The device falls under product code QJF, Autofluorescence Imaging Adjunct Tool For Wounds, regulated at 21 CFR 878.4550 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on May 30, 2025. The decision came 270 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 Swift Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251678?

K251678 is the FDA 510(k) for Swift Ray 1, submitted by Swift Medical, Inc.. FDA's decision date was Feb 24, 2026, under product code QJF (Autofluorescence Imaging Adjunct Tool For Wounds).

Who makes the Swift Ray 1?

Swift Medical, Inc., based in Toronto, is the applicant of record for K251678.

How long did the K251678 review take?

FDA received the submission on May 30, 2025 and issued its decision on Feb 24, 2026, 270 days later.

← All decisions in February 2026