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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 / May 2026 / K252823

510(k) cleared

Dukal Crepe Paper Sterilization Wrap

Dukal, LLC · May 28, 2026 · K252823

FDA cleared the Dukal Crepe Paper Sterilization Wrap from Dukal, LLC on May 28, 2026 under K252823, a traditional 510(k). The device falls under product code FRG, Wrap, Sterilization, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 4, 2025. The decision came 266 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 Dukal, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252823?

K252823 is the FDA 510(k) for Dukal Crepe Paper Sterilization Wrap, submitted by Dukal, LLC. FDA's decision date was May 28, 2026, under product code FRG (Wrap, Sterilization).

Who makes the Dukal Crepe Paper Sterilization Wrap?

Dukal, LLC, based in Ronkonkoma, NY, is the applicant of record for K252823.

How long did the K252823 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on May 28, 2026, 266 days later.

← All decisions in May 2026