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THE TAPE

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 / November 2025 / K251756

510(k) cleared

Sterilization Trays

Paragon Implant Mfg., LLC · Nov 14, 2025 · K251756

FDA cleared the Sterilization Trays from Paragon Implant Mfg., LLC on Nov 14, 2025 under K251756, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jun 9, 2025. The decision came 158 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Paragon Implant Mfg., LLC has 3 other decisions in the tracker over the last 12 months: K250476 (NizPlant Dental Implant System), K252145 (GEN5 and GEN5+ 3.3mmD Dental Implants), K251938 (GEN5 and GEN5+ Dental Implant System).

Questions & Answers

What did FDA clear under K251756?

K251756 is the FDA 510(k) for Sterilization Trays, submitted by Paragon Implant Mfg., LLC. FDA's decision date was Nov 14, 2025, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the Sterilization Trays?

Paragon Implant Mfg., LLC, based in Calabasas, CA, is the applicant of record for K251756.

How long did the K251756 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Nov 14, 2025, 158 days later.

← All decisions in November 2025

Sources