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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 / K260857

510(k) cleared

Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set

Sol-Millennium Medical, Inc. · Oct 21, 2026 · K260857

FDA cleared the Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set from Sol-Millennium Medical, Inc. on Oct 21, 2026 under K260857, a special 510(k). The device falls under product code JKA, Tubes, Vials, Systems, Serum Separators, Blood Collection, regulated at 21 CFR 862.1675 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Mar 16, 2026. The decision came 219 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sol-Millennium Medical, Inc. has 2 other decisions in the tracker over the last 12 months: K252184 (SOL-M Luer Lock Syringe with Exchangeable Needle Tray), K253110 (Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe).

Questions & Answers

What did FDA clear under K260857?

K260857 is the FDA 510(k) for Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set, submitted by Sol-Millennium Medical, Inc.. FDA's decision date was Oct 21, 2026, under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

Who makes the Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set?

Sol-Millennium Medical, Inc., based in Chicago, IL, is the applicant of record for K260857.

How long did the K260857 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Oct 21, 2026, 219 days later.

← All decisions in October 2026

Sources