WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K253437

510(k) cleared

Spiro-VISTA

Spiro Robotics · Jun 12, 2026 · K253437

FDA cleared the Spiro-VISTA from Spiro Robotics on Jun 12, 2026 under K253437, a traditional 510(k). The device falls under product code BTR, Tube, Tracheal (W/Wo Connector), regulated at 21 CFR 868.5730 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Oct 1, 2025. The decision came 254 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 Spiro Robotics in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253437?

K253437 is the FDA 510(k) for Spiro-VISTA, submitted by Spiro Robotics. FDA's decision date was Jun 12, 2026, under product code BTR (Tube, Tracheal (W/Wo Connector)).

Who makes the Spiro-VISTA?

Spiro Robotics, based in Hayward, CA, is the applicant of record for K253437.

How long did the K253437 review take?

FDA received the submission on Oct 1, 2025 and issued its decision on Jun 12, 2026, 254 days later.

← All decisions in June 2026