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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 / K252066

510(k) cleared

inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)

Vincent Healthcare Products Limited · Jun 18, 2026 · K252066

FDA cleared the inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) from Vincent Healthcare Products Limited on Jun 18, 2026 under K252066, a traditional 510(k). The device falls under product code BZE, Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, regulated at 21 CFR 868.5270 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Jul 1, 2025. The decision came 352 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 Vincent Healthcare Products Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252066?

K252066 is the FDA 510(k) for inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20), submitted by Vincent Healthcare Products Limited. FDA's decision date was Jun 18, 2026, under product code BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer).

Who makes the inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20)?

Vincent Healthcare Products Limited, based in Kowloon, is the applicant of record for K252066.

How long did the K252066 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Jun 18, 2026, 352 days later.

← All decisions in June 2026