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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 / K252874

510(k) cleared

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

Serpex Medical, Inc. · Oct 8, 2025 · K252874

FDA cleared the Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 from Serpex Medical, Inc. on Oct 8, 2025 under K252874, a special 510(k). The device falls under product code KTI, Bronchoscope Accessory, regulated at 21 CFR 874.4680 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Sep 10, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Serpex Medical, Inc. has one other decision in the tracker over the last 12 months: K261068 (Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)).

Questions & Answers

What did FDA clear under K252874?

K252874 is the FDA 510(k) for Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01, submitted by Serpex Medical, Inc.. FDA's decision date was Oct 8, 2025, under product code KTI (Bronchoscope Accessory).

Who makes the Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01?

Serpex Medical, Inc., based in Santa Clara, CA, is the applicant of record for K252874.

How long did the K252874 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Oct 8, 2025, 28 days later.

← All decisions in October 2025

Sources