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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 / July 2026 / K261212

510(k) cleared

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

ACON Laboratories, Inc. · Jul 10, 2026 · K261212

FDA cleared the Flowflex Plus RSV + Flu A/B + COVID Rapid Test from ACON Laboratories, Inc. on Jul 10, 2026 under K261212, a dual track 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 14, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

ACON Laboratories, Inc. has 3 other decisions in the tracker over the last 12 months: K251697 (Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip), K251749 (Flowflex Plus RSV + Flu A/B + COVID Home Test), 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 K261212?

K261212 is the FDA 510(k) for Flowflex Plus RSV + Flu A/B + COVID Rapid Test, submitted by ACON Laboratories, Inc.. FDA's decision date was Jul 10, 2026, under product code SCA (Multi-Analyte Respiratory Virus Antigen Detection Test).

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

ACON Laboratories, Inc., based in San Diego, CA, is the applicant of record for K261212.

How long did the K261212 review take?

FDA received the submission on Apr 14, 2026 and issued its decision on Jul 10, 2026, 87 days later.

← All decisions in July 2026