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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 / June 2026 / K252932

510(k) cleared

Fast PCR Mini Respiratory Panel

Autonomous Medical Devices Incorporated · Jun 12, 2026 · K252932

FDA cleared the Fast PCR Mini Respiratory Panel from Autonomous Medical Devices Incorporated on Jun 12, 2026 under K252932, a dual track 510(k). The device falls under product code QOF, Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, regulated at 21 CFR 866.3981 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Sep 15, 2025. The decision came 270 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 Autonomous Medical Devices Incorporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252932?

K252932 is the FDA 510(k) for Fast PCR Mini Respiratory Panel, submitted by Autonomous Medical Devices Incorporated. FDA's decision date was Jun 12, 2026, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the Fast PCR Mini Respiratory Panel?

Autonomous Medical Devices Incorporated, based in Santa Ana, CA, is the applicant of record for K252932.

How long did the K252932 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Jun 12, 2026, 270 days later.

← All decisions in June 2026