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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 / October 2025 / K252140

510(k) cleared

Heylo System

Coloplast Corp. · Oct 6, 2025 · K252140

FDA cleared the Heylo System from Coloplast Corp. on Oct 6, 2025 under K252140, a traditional 510(k). The device falls under product code EXB, Collector, Ostomy, regulated at 21 CFR 876.5900 as a Class 1 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 8, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Coloplast Corp. has one other decision in the tracker over the last 12 months: K262045 (Luja Soft).

Questions & Answers

What did FDA clear under K252140?

K252140 is the FDA 510(k) for Heylo System, submitted by Coloplast Corp.. FDA's decision date was Oct 6, 2025, under product code EXB (Collector, Ostomy).

Who makes the Heylo System?

Coloplast Corp., based in Plymouth, MN, is the applicant of record for K252140.

How long did the K252140 review take?

FDA received the submission on Jul 8, 2025 and issued its decision on Oct 6, 2025, 90 days later.

← All decisions in October 2025