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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262136

510(k) cleared

BIOFIRE SPOTFIRE Vaginitis (VG) Panel

Biofire Diagnostics, LLC · Oct 21, 2026 · K262136

FDA cleared the BIOFIRE SPOTFIRE Vaginitis (VG) Panel from Biofire Diagnostics, LLC on Oct 21, 2026 under K262136, a dual track 510(k). The device falls under product code PQA, Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, regulated at 21 CFR 866.3975 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jun 25, 2026. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Biofire Diagnostics, LLC has one other decision in the tracker over the last 12 months: K263054 (BIOFIRE Respiratory Panel 2.1 (RP2.1)).

Questions & Answers

What did FDA clear under K262136?

K262136 is the FDA 510(k) for BIOFIRE SPOTFIRE Vaginitis (VG) Panel, submitted by Biofire Diagnostics, LLC. FDA's decision date was Oct 21, 2026, under product code PQA (Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System).

Who makes the BIOFIRE SPOTFIRE Vaginitis (VG) Panel?

Biofire Diagnostics, LLC, based in Salt Lake City, UT, is the applicant of record for K262136.

How long did the K262136 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Oct 21, 2026, 118 days later.

← All decisions in October 2026

Sources