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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 / K251874

510(k) cleared

PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

Pureway Compliance, Inc. · Oct 14, 2025 · K251874

FDA cleared the PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) from Pureway Compliance, Inc. on Oct 14, 2025 under K251874, 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 Jun 18, 2025. The decision came 118 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 Pureway Compliance, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251874?

K251874 is the FDA 510(k) for PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013), submitted by Pureway Compliance, Inc.. FDA's decision date was Oct 14, 2025, under product code MMK (Container, Sharps).

Who makes the PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)?

Pureway Compliance, Inc., based in Katy, TX, is the applicant of record for K251874.

How long did the K251874 review take?

FDA received the submission on Jun 18, 2025 and issued its decision on Oct 14, 2025, 118 days later.

← All decisions in October 2025