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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 / June 2026 / K253274

510(k) cleared

BedDot (G1)

Intelligent Dots, LLC · Jun 25, 2026 · K253274

FDA cleared the BedDot (G1) from Intelligent Dots, LLC on Jun 25, 2026 under K253274, a traditional 510(k). The device falls under product code BZQ, Monitor, Breathing Frequency, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 269 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 Intelligent Dots, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253274?

K253274 is the FDA 510(k) for BedDot (G1), submitted by Intelligent Dots, LLC. FDA's decision date was Jun 25, 2026, under product code BZQ (Monitor, Breathing Frequency).

Who makes the BedDot (G1)?

Intelligent Dots, LLC, based in Peachtree Corner, GA, is the applicant of record for K253274.

How long did the K253274 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 25, 2026, 269 days later.

← All decisions in June 2026