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510(k) K253110

Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe by Sol-Millennium Medical, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
September 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Sol-Millennium Medical, Inc.

  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
  • K242291 — SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low (November 20, 2024)
  • K242099 — Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Nee (October 22, 2024)
  • K241821 — Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle (September 20, 2024)
  • K220713 — Sol-Guard Auto-disable Syringe (May 4, 2023)
  • K222744 — Sol-M Luer Lock Syringe (October 11, 2022)
  • K213718 — SOL-GUARD Safety Pull Button Collection Set (August 30, 2022)
  • K182146 — Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Ca (December 3, 2018)
  • K163073 — Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder (May 19, 2017)
  • K162030 — 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle (August 19, 2016)

Other clearances for product code FMF

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  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K250510 — Sure-Fine Insulin Syringes (October 15, 2025)