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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 / K262573

510(k) cleared

SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control

Maine Molecular Quality Controls, Inc. · Oct 21, 2026 · K262573

FDA cleared the SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control from Maine Molecular Quality Controls, Inc. on Oct 21, 2026 under K262573, a traditional 510(k). The device falls under product code PMN, Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays, regulated at 21 CFR 866.3920 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 27, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

Maine Molecular Quality Controls, Inc. has one other decision in the tracker over the last 12 months: K260577 (FilmArray TF Control Panel M527).

Questions & Answers

What did FDA clear under K262573?

K262573 is the FDA 510(k) for SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control, submitted by Maine Molecular Quality Controls, Inc.. FDA's decision date was Oct 21, 2026, under product code PMN (Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays).

Who makes the SPOTFIRE VG Control Panel M534, SPOTFIRE VG Negative Control?

Maine Molecular Quality Controls, Inc., based in Saco, ME, is the applicant of record for K262573.

How long did the K262573 review take?

FDA received the submission on Jul 27, 2026 and issued its decision on Oct 21, 2026, 86 days later.

← All decisions in October 2026

Sources