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The Tracker / August 2026 / K252184

510(k) cleared

SOL-M Luer Lock Syringe with Exchangeable Needle Tray

Sol-Millennium Medical, Inc. · Aug 25, 2026 · K252184

FDA cleared the SOL-M Luer Lock Syringe with Exchangeable Needle Tray from Sol-Millennium Medical, Inc. on Aug 25, 2026 under K252184, 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 Jul 11, 2025. The decision came 410 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: K253110 (Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe).

Questions & Answers

What did FDA clear under K252184?

K252184 is the FDA 510(k) for SOL-M Luer Lock Syringe with Exchangeable Needle Tray, submitted by Sol-Millennium Medical, Inc.. FDA's decision date was Aug 25, 2026, under product code FMF (Syringe, Piston).

Who makes the SOL-M Luer Lock Syringe with Exchangeable Needle Tray?

Sol-Millennium Medical, Inc., based in Chicago, IL, is the applicant of record for K252184.

How long did the K252184 review take?

FDA received the submission on Jul 11, 2025 and issued its decision on Aug 25, 2026, 410 days later.

← All decisions in August 2026

Sources