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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 / K251218

510(k) cleared

SafeBeat Rx App

SafeBeat Rx, Inc. · Feb 6, 2026 · K251218

FDA cleared the SafeBeat Rx App from SafeBeat Rx, Inc. on Feb 6, 2026 under K251218, a traditional 510(k). The device falls under product code DQK, Computer, Diagnostic, Programmable, regulated at 21 CFR 870.1425 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Apr 21, 2025. The decision came 291 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 SafeBeat Rx, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251218?

K251218 is the FDA 510(k) for SafeBeat Rx App, submitted by SafeBeat Rx, Inc.. FDA's decision date was Feb 6, 2026, under product code DQK (Computer, Diagnostic, Programmable).

Who makes the SafeBeat Rx App?

SafeBeat Rx, Inc., based in San Francisco, CA, is the applicant of record for K251218.

How long did the K251218 review take?

FDA received the submission on Apr 21, 2025 and issued its decision on Feb 6, 2026, 291 days later.

← All decisions in February 2026