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 / December 2025 / K251092

510(k) cleared

iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro

Ihealth Labs, Inc. · Dec 12, 2025 · K251092

FDA cleared the iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro from Ihealth Labs, Inc. on Dec 12, 2025 under K251092, a traditional 510(k). The device falls under product code SCA, Multi-Analyte Respiratory Virus Antigen Detection Test, regulated at 21 CFR 866.3987 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Apr 10, 2025. The decision came 246 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Ihealth Labs, Inc. has one other decision in the tracker over the last 12 months: K251085 (iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro).

Questions & Answers

What did FDA clear under K251092?

K251092 is the FDA 510(k) for iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro, submitted by Ihealth Labs, Inc.. FDA's decision date was Dec 12, 2025, under product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test).

Who makes the iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro?

Ihealth Labs, Inc., based in Sunnyvale, CA, is the applicant of record for K251092.

How long did the K251092 review take?

FDA received the submission on Apr 10, 2025 and issued its decision on Dec 12, 2025, 246 days later.

← All decisions in December 2025

Sources