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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 / K252355

510(k) cleared

K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing

Sb-Kawasumi Laboratories, Inc. · Nov 26, 2025 · K252355

FDA cleared the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing from Sb-Kawasumi Laboratories, Inc. on Nov 26, 2025 under K252355, a traditional 510(k). The device falls under product code PTI, Non-Coring (Huber) Needle, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jul 29, 2025. The decision came 120 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 Sb-Kawasumi Laboratories, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252355?

K252355 is the FDA 510(k) for K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing, submitted by Sb-Kawasumi Laboratories, Inc.. FDA's decision date was Nov 26, 2025, under product code PTI (Non-Coring (Huber) Needle).

Who makes the K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing?

Sb-Kawasumi Laboratories, Inc., based in Kanagawa, is the applicant of record for K252355.

How long did the K252355 review take?

FDA received the submission on Jul 29, 2025 and issued its decision on Nov 26, 2025, 120 days later.

← All decisions in November 2025