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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 / May 2026 / K260213

510(k) cleared

BD BACTEC FXI Culture System

BD Diagnostic Systems · May 28, 2026 · K260213

FDA cleared the BD BACTEC FXI Culture System from BD Diagnostic Systems on May 28, 2026 under K260213, a traditional 510(k). The device falls under product code MDB, System, Blood Culturing, regulated at 21 CFR 866.2560 as a Class 1 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 23, 2026. The decision came 125 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 BD Diagnostic Systems in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260213?

K260213 is the FDA 510(k) for BD BACTEC FXI Culture System, submitted by BD Diagnostic Systems. FDA's decision date was May 28, 2026, under product code MDB (System, Blood Culturing).

Who makes the BD BACTEC FXI Culture System?

BD Diagnostic Systems, based in Sparks, MD, is the applicant of record for K260213.

How long did the K260213 review take?

FDA received the submission on Jan 23, 2026 and issued its decision on May 28, 2026, 125 days later.

← All decisions in May 2026