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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 / March 2026 / K252269

510(k) cleared

FINDER Flu A&B/SARS-CoV-2 Test

Baebies, Inc. · Mar 30, 2026 · K252269

FDA cleared the FINDER Flu A&B/SARS-CoV-2 Test from Baebies, Inc. on Mar 30, 2026 under K252269, a dual track 510(k). The device falls under product code QOF, Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents, regulated at 21 CFR 866.3981 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 21, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Baebies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252269?

K252269 is the FDA 510(k) for FINDER Flu A&B/SARS-CoV-2 Test, submitted by Baebies, Inc.. FDA's decision date was Mar 30, 2026, under product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents).

Who makes the FINDER Flu A&B/SARS-CoV-2 Test?

Baebies, Inc., based in Durham, NC, is the applicant of record for K252269.

How long did the K252269 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Mar 30, 2026, 252 days later.

← All decisions in March 2026