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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 / K252637

510(k) cleared

Community Containers (Flap and Daisy)

Keter Canada, Inc. · Oct 14, 2025 · K252637

FDA cleared the Community Containers (Flap and Daisy) from Keter Canada, Inc. on Oct 14, 2025 under K252637, a traditional 510(k). The device falls under product code MMK, Container, Sharps, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Aug 20, 2025. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Keter Canada, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252637?

K252637 is the FDA 510(k) for Community Containers (Flap and Daisy), submitted by Keter Canada, Inc.. FDA's decision date was Oct 14, 2025, under product code MMK (Container, Sharps).

Who makes the Community Containers (Flap and Daisy)?

Keter Canada, Inc., based in Milton, is the applicant of record for K252637.

How long did the K252637 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Oct 14, 2025, 55 days later.

← All decisions in October 2025