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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 / November 2025 / K252964

510(k) cleared

PRIMED Surgical and Procedure Masks

Primed Medical Products, Inc. · Nov 4, 2025 · K252964

FDA cleared the PRIMED Surgical and Procedure Masks from Primed Medical Products, Inc. on Nov 4, 2025 under K252964, a traditional 510(k). The device falls under product code FXX, Mask, Surgical, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 17, 2025. The decision came 48 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Primed Medical Products, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252964?

K252964 is the FDA 510(k) for PRIMED Surgical and Procedure Masks, submitted by Primed Medical Products, Inc.. FDA's decision date was Nov 4, 2025, under product code FXX (Mask, Surgical).

Who makes the PRIMED Surgical and Procedure Masks?

Primed Medical Products, Inc., based in Edmonton, is the applicant of record for K252964.

How long did the K252964 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Nov 4, 2025, 48 days later.

← All decisions in November 2025