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THE TAPE

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 / February 2026 / K252523

510(k) cleared

Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test

Healgen Scientific,, LLC · Feb 12, 2026 · K252523

FDA cleared the Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test from Healgen Scientific,, LLC on Feb 12, 2026 under K252523, a traditional 510(k). The device falls under product code NFW, Test, Cannabinoid, Over The Counter, regulated at 21 CFR 862.3870 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Aug 11, 2025. The decision came 185 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Healgen Scientific,, LLC has 4 other decisions in the tracker over the last 12 months: K260095 (Heal-Check Rapid COVID-19 Antigen Self-Test), K253705 (Healgen® Accurate Oral Fluid Drug Test), K251800 (Healgen® URS Test Strips), K253567 (Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card).

Questions & Answers

What did FDA clear under K252523?

K252523 is the FDA 510(k) for Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test, submitted by Healgen Scientific,, LLC. FDA's decision date was Feb 12, 2026, under product code NFW (Test, Cannabinoid, Over The Counter).

Who makes the Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test?

Healgen Scientific,, LLC, based in Houston, TX, is the applicant of record for K252523.

How long did the K252523 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Feb 12, 2026, 185 days later.

← All decisions in February 2026

Sources