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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261837

510(k) cleared

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

Baebies, Inc. · Sep 11, 2026 · K261837

FDA cleared the FINDER Flu A&B/SARS-CoV-2 Test from Baebies, Inc. on Sep 11, 2026 under K261837, a traditional 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 Jun 2, 2026. The decision came 101 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Baebies, Inc. has one other decision in the tracker over the last 12 months: K252269 (FINDER Flu A&B/SARS-CoV-2 Test).

Questions & Answers

What did FDA clear under K261837?

K261837 is the FDA 510(k) for FINDER Flu A&B/SARS-CoV-2 Test, submitted by Baebies, Inc.. FDA's decision date was Sep 11, 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 K261837.

How long did the K261837 review take?

FDA received the submission on Jun 2, 2026 and issued its decision on Sep 11, 2026, 101 days later.

← All decisions in September 2026

Sources