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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 / October 2025 / K251749

510(k) cleared

Flowflex Plus RSV + Flu A/B + COVID Home Test

ACON Laboratories, Inc. · Oct 22, 2025 · K251749

FDA cleared the Flowflex Plus RSV + Flu A/B + COVID Home Test from ACON Laboratories, Inc. on Oct 22, 2025 under K251749, 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 Jun 6, 2025. The decision came 138 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ACON Laboratories, Inc. has 3 other decisions in the tracker over the last 12 months: K261212 (Flowflex Plus RSV + Flu A/B + COVID Rapid Test), K251697 (Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip), K250085 (On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System).

Questions & Answers

What did FDA clear under K251749?

K251749 is the FDA 510(k) for Flowflex Plus RSV + Flu A/B + COVID Home Test, submitted by ACON Laboratories, Inc.. FDA's decision date was Oct 22, 2025, under product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test).

Who makes the Flowflex Plus RSV + Flu A/B + COVID Home Test?

ACON Laboratories, Inc., based in San Diego, CA, is the applicant of record for K251749.

How long did the K251749 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Oct 22, 2025, 138 days later.

← All decisions in October 2025