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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / June 2026 / K253110

510(k) cleared

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe

Sol-Millennium Medical, Inc. · Jun 18, 2026 · K253110

FDA cleared the Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe from Sol-Millennium Medical, Inc. on Jun 18, 2026 under K253110, a traditional 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 24, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sol-Millennium Medical, Inc. has one other decision in the tracker over the last 12 months: K252184 (SOL-M Luer Lock Syringe with Exchangeable Needle Tray).

Questions & Answers

What did FDA clear under K253110?

K253110 is the FDA 510(k) for Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe, submitted by Sol-Millennium Medical, Inc.. FDA's decision date was Jun 18, 2026, under product code FMF (Syringe, Piston).

Who makes the Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe?

Sol-Millennium Medical, Inc., based in Chicago, IL, is the applicant of record for K253110.

How long did the K253110 review take?

FDA received the submission on Sep 24, 2025 and issued its decision on Jun 18, 2026, 267 days later.

← All decisions in June 2026

Sources