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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 / March 2026 / K260448

510(k) cleared

CastleLoc Pectus Bar System

L&K BIOMED Co., Ltd. · Mar 19, 2026 · K260448

FDA cleared the CastleLoc Pectus Bar System from L&K BIOMED Co., Ltd. on Mar 19, 2026 under K260448, a special 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 11, 2026. The decision came 36 days later, inside the 90 FDA-day goal for a 510(k).

L&K BIOMED Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K260840 (BluEX Cervical Expandable Cage System), K261112 (CastleLoc-P Anterior Cervical Plate System), K261130 (AccelFix Spinal Fixation System), K251940 (PathLoc Lumbar Plate System).

Questions & Answers

What did FDA clear under K260448?

K260448 is the FDA 510(k) for CastleLoc Pectus Bar System, submitted by L&K BIOMED Co., Ltd.. FDA's decision date was Mar 19, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the CastleLoc Pectus Bar System?

L&K BIOMED Co., Ltd., based in Yongin-Si, is the applicant of record for K260448.

How long did the K260448 review take?

FDA received the submission on Feb 11, 2026 and issued its decision on Mar 19, 2026, 36 days later.

← All decisions in March 2026

Sources