WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / April 2026 / K260095

510(k) cleared

Heal-Check Rapid COVID-19 Antigen Self-Test

Healgen Scientific,, LLC · Apr 13, 2026 · K260095

FDA cleared the Heal-Check Rapid COVID-19 Antigen Self-Test from Healgen Scientific,, LLC on Apr 13, 2026 under K260095, a traditional 510(k). The device falls under product code QYT, Over-The-Counter Covid-19 Antigen Test, regulated at 21 CFR 866.3984 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jan 13, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Healgen Scientific,, LLC has 4 other decisions in the tracker over the last 12 months: K253705 (Healgen® Accurate Oral Fluid Drug 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 K260095?

K260095 is the FDA 510(k) for Heal-Check Rapid COVID-19 Antigen Self-Test, submitted by Healgen Scientific,, LLC. FDA's decision date was Apr 13, 2026, under product code QYT (Over-The-Counter Covid-19 Antigen Test).

Who makes the Heal-Check Rapid COVID-19 Antigen Self-Test?

Healgen Scientific,, LLC, based in Houston, TX, is the applicant of record for K260095.

How long did the K260095 review take?

FDA received the submission on Jan 13, 2026 and issued its decision on Apr 13, 2026, 90 days later.

← All decisions in April 2026