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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 / December 2025 / K251800

510(k) cleared

Healgen® URS Test Strips

Healgen Scientific,, LLC · Dec 23, 2025 · K251800

FDA cleared the Healgen® URS Test Strips from Healgen Scientific,, LLC on Dec 23, 2025 under K251800, a traditional 510(k). The device falls under product code JMT, Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), regulated at 21 CFR 862.1510 as a Class 1 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 12, 2025. The decision came 194 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), K252523 (Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test), K253567 (Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card).

Questions & Answers

What did FDA clear under K251800?

K251800 is the FDA 510(k) for Healgen® URS Test Strips, submitted by Healgen Scientific,, LLC. FDA's decision date was Dec 23, 2025, under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)).

Who makes the Healgen® URS Test Strips?

Healgen Scientific,, LLC, based in Houston, TX, is the applicant of record for K251800.

How long did the K251800 review take?

FDA received the submission on Jun 12, 2025 and issued its decision on Dec 23, 2025, 194 days later.

← All decisions in December 2025