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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 / K250306

510(k) cleared

Chex-All Sterilization Pouches and Tubes

Propper Manufacturing Co., Inc. · Oct 31, 2025 · K250306

FDA cleared the Chex-All Sterilization Pouches and Tubes from Propper Manufacturing Co., Inc. on Oct 31, 2025 under K250306, a abbreviated 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 Feb 3, 2025. The decision came 270 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 Propper Manufacturing Co., Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250306?

K250306 is the FDA 510(k) for Chex-All Sterilization Pouches and Tubes, submitted by Propper Manufacturing Co., Inc.. FDA's decision date was Oct 31, 2025, under product code FRG (Wrap, Sterilization).

Who makes the Chex-All Sterilization Pouches and Tubes?

Propper Manufacturing Co., Inc., based in Long Island, NY, is the applicant of record for K250306.

How long did the K250306 review take?

FDA received the submission on Feb 3, 2025 and issued its decision on Oct 31, 2025, 270 days later.

← All decisions in October 2025