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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 / September 2025 / K252520

510(k) cleared

SEFRIA Hydrocodone Oral Fluid

Immunalysis Corporation · Sep 11, 2025 · K252520

FDA cleared the SEFRIA Hydrocodone Oral Fluid from Immunalysis Corporation on Sep 11, 2025 under K252520, a traditional 510(k). The device falls under product code DJG, Enzyme Immunoassay, Opiates, regulated at 21 CFR 862.3650 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Aug 11, 2025. The decision came 31 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Immunalysis Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252520?

K252520 is the FDA 510(k) for SEFRIA Hydrocodone Oral Fluid, submitted by Immunalysis Corporation. FDA's decision date was Sep 11, 2025, under product code DJG (Enzyme Immunoassay, Opiates).

Who makes the SEFRIA Hydrocodone Oral Fluid?

Immunalysis Corporation, based in Pomona, CA, is the applicant of record for K252520.

How long did the K252520 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Sep 11, 2025, 31 days later.

← All decisions in September 2025