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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 / K254139

510(k) cleared

BioCode® Respiratory Pathogen Panel (RPP)

Applied BioCode, Inc. · May 1, 2026 · K254139

FDA cleared the BioCode® Respiratory Pathogen Panel (RPP) from Applied BioCode, Inc. on May 1, 2026 under K254139, a traditional 510(k). The device falls under product code OCC, Respiratory Virus Panel Nucleic Acid Assay System, regulated at 21 CFR 866.3980 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Dec 22, 2025. The decision came 130 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 Applied BioCode, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254139?

K254139 is the FDA 510(k) for BioCode® Respiratory Pathogen Panel (RPP), submitted by Applied BioCode, Inc.. FDA's decision date was May 1, 2026, under product code OCC (Respiratory Virus Panel Nucleic Acid Assay System).

Who makes the BioCode® Respiratory Pathogen Panel (RPP)?

Applied BioCode, Inc., based in Santa Fe Springs, CA, is the applicant of record for K254139.

How long did the K254139 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on May 1, 2026, 130 days later.

← All decisions in May 2026