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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 / March 2026 / K253705

510(k) cleared

Healgen® Accurate Oral Fluid Drug Test

Healgen Scientific,, LLC · Mar 16, 2026 · K253705

FDA cleared the Healgen® Accurate Oral Fluid Drug Test from Healgen Scientific,, LLC on Mar 16, 2026 under K253705, a traditional 510(k). The device falls under product code DJC, Thin Layer Chromatography, Methamphetamine, regulated at 21 CFR 862.3610 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Nov 24, 2025. The decision came 112 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), K252523 (Healgen® Accurate Oral Fluid Drug Test COT/THC; 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 K253705?

K253705 is the FDA 510(k) for Healgen® Accurate Oral Fluid Drug Test, submitted by Healgen Scientific,, LLC. FDA's decision date was Mar 16, 2026, under product code DJC (Thin Layer Chromatography, Methamphetamine).

Who makes the Healgen® Accurate Oral Fluid Drug Test?

Healgen Scientific,, LLC, based in Houston, TX, is the applicant of record for K253705.

How long did the K253705 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Mar 16, 2026, 112 days later.

← All decisions in March 2026